Product Code: DXY
FDA class 3
21 CFR 870.3610
Implantable Pacemaker Pulse-Generator
Cardiovascular
The Implantable Pacemaker Pulse Generator is a cardiovascular device surgically implanted in the body to deliver controlled electrical impulses to stimulate the heart when its natural rhythm is inadequate or absent. It is classified as FDA Class 3, the highest risk category, which requires approval through a Premarket Approval (PMA) application demonstrating safety and effectiveness. The product code is DXY and the applicable regulation is 21 CFR 870.3610, under the Cardiovascular medical specialty. This device is an implant.
510(k)s
461
FEI Numbers
28
Registration Numbers
28
Unique Applicants
48
Years Active
23
Basic Information
- Product Code
- DXY
- Device Class
- FDA class 3
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
✗
GMP Exempt
✓
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
Loading...
Related 510(k) Clearances
This FDA classification is associated with 461 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K993434 | PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A | Nov 10, 1999 | Substantially Equivalent | BIOTRONIK, INC. |
| K970072 | OPUS S MODEL 4121 AND 4124 PACEMAKERS | Aug 29, 1997 | Substantially Equivalent - Subject to Tracking Reg. | ELA MEDICAL, INC. |
| K945627 | PIKOS LP 01, PIKOS LP E01 | Mar 04, 1996 | Unknown | BIOTRONIK, INC. |
| K954092 | ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) | Dec 15, 1995 | Substantially Equivalent - Subject to Tracking Reg. | MEDTRONIC VASCULAR |
| K953866 | MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) | Dec 15, 1995 | Substantially Equivalent - Subject to Tracking Reg. | MEDTRONIC VASCULAR |
| K953417 | MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS | Sep 29, 1995 | Substantially Equivalent - Subject to Tracking Reg. | COOK PACEMAKER CORP. |
| K952328 | NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 | Sep 29, 1995 | Substantially Equivalent - Subject to Tracking Reg. | BIOTRONIK, INC. |
| K952364 | OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) | Sep 01, 1995 | Substantially Equivalent - Subject to Tracking Reg. | ELA MEDICAL, INC. |
| K940039 | PELLETHANE 75D | Jul 12, 1995 | Substantially Equivalent - Subject to Tracking Reg. | MEDTRONIC VASCULAR |
| K950751 | TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES | May 15, 1995 | Substantially Equivalent - Subject to Tracking Reg. | MEDTRONIC VASCULAR |
| K946188 | CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER | May 15, 1995 | Substantially Equivalent - Subject to Tracking Reg. | CARDIAC CONTROL SYSTEMS, INC. |
| K950210 | CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER | May 03, 1995 | Substantially Equivalent - Subject to Tracking Reg. | CARDIAC CONTROL SYSTEMS, INC. |
| K941937 | PIKOS E 01-B | Aug 30, 1994 | Unknown | BIOTRONIK, INC. |
| K932884 | MINIX/MINIX ST PULSE GENERATORS | May 02, 1994 | Unknown | MEDTRONIC VASCULAR |
| K923026 | PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER | Aug 19, 1993 | Substantially Equivalent | BIOTRONIK, GMBH & CO. |
| K930770 | MEDTRONIC MINIX & MINIX ST PULSE GENERATORS | May 14, 1993 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K923868 | CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER | May 14, 1993 | Substantially Equivalent | CARDIAC CONTROL SYSTEMS, INC. |
| K920601 | ASTRA T2, ASTRA T4, ASTRA T6 | Oct 28, 1992 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K920530 | INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG | Mar 17, 1992 | Substantially Equivalent | INTERMEDICS, INC. |
| K920157 | SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER | Mar 16, 1992 | Substantially Equivalent | SCHNEIDER INTL., LTD. |
| K914109 | PIKOS 01 & PIKOS E 01 | Feb 26, 1992 | Substantially Equivalent | BIOTRONIK, GMBH & CO. |
| K905403 | MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER | Oct 16, 1991 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K913134 | MODEL 4220 | Aug 22, 1991 | Substantially Equivalent | PACE MEDICAL |
| K912545 | MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE | Jul 26, 1991 | Substantially Equivalent | PACE MEDICAL |
| K911122 | 8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS | May 16, 1991 | Substantially Equivalent | INTERMEDICS, INC. |
| K905824 | MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE | May 16, 1991 | Substantially Equivalent | CARDIAC CONTROL SYSTEMS, INC. |
| K905087 | TRIOS 02 | May 07, 1991 | Substantially Equivalent | BIOTRONIK, GMBH & CO. |
| K903186 | OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE | Jan 18, 1991 | Substantially Equivalent | TELECTRONICS PACING SYSTEMS, INC. |
| K904941 | MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE | Jan 03, 1991 | Substantially Equivalent | CARDIAC CONTROL SYSTEMS, INC. |
| K904602 | MEDTRONIC MODEL 5301B TEST CABLE | Jan 03, 1991 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K904892 | VACUUM BAKE CYCLE | Dec 20, 1990 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K903919 | IMPLANTABLE PULSE DEVICES | Oct 23, 1990 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K903081 | NEOS (TM) 02 B PULSE GENERATOR | Sep 14, 1990 | Substantially Equivalent | BIOTRONIK, GMBH & CO. |
| K902134 | MINIX, MINIX ST, NEW IC: L74 | Jul 03, 1990 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K901535 | MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE. | Jul 03, 1990 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K900622 | MODIFIED MODEL 5401B TEST CABLE | Apr 26, 1990 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K900461 | OPUS MODEL 4021, VVI, 5MM UNIPOLAR | Mar 14, 1990 | Substantially Equivalent | ELA MEDICAL, INC. |
| K897116 | OPTIMA MPT MODEL 5281E AND MODEL 5282E | Mar 14, 1990 | Substantially Equivalent | TELECTRONICS PACING SYSTEMS, INC. |
| K896809 | MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR | Jan 26, 1990 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K896184 | KALOS 05 PULSE GENERATOR | Jan 18, 1990 | Substantially Equivalent | BIOTRONIK CARDIAC PACEMAKERS |
| K894239 | NANOS | Nov 01, 1989 | Substantially Equivalent | BIOTRONIK CARDIAC PACEMAKERS |
| K894240 | NEOS 02 | Oct 26, 1989 | Substantially Equivalent | BIOTRONIK CARDIAC PACEMAKERS |
| K894494 | LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD | Oct 17, 1989 | Substantially Equivalent | BIOTRONIK, GMBH & CO. |
| K895495 | ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS | Sep 26, 1989 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K894065 | OPUS MODEL 4001 | Sep 26, 1989 | Substantially Equivalent | ELA MEDICAL, INC. |
| K894267 | OPUS MODELS 4033 AND 4034 | Sep 20, 1989 | Substantially Equivalent | ELA MEDICAL, INC. |
| K891231 | OPTIMA MPT AND SPT PACEMAKERS | Sep 12, 1989 | Substantially Equivalent | TELECTRONICS, INC. |
| K894055 | MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS | Aug 25, 1989 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K884420 | HOME BLOOD PRESSURE KIT, ANEROID | Aug 25, 1989 | Substantially Equivalent | YAMASU CO. LTD. |
| K894185 | OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR | Aug 17, 1989 | Substantially Equivalent | TELECTRONICS PACING SYSTEMS, INC. |
| K885267 | VS-1 MODEL NUMBER 251K PULSE GENERATOR | Mar 28, 1989 | Substantially Equivalent | PACESETTER SYSTEMS |
| K890785 | ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE | Mar 10, 1989 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K884733 | AFP MODEL 262T PULSE GENERATOR | Feb 10, 1989 | Substantially Equivalent | PACESETTER SYSTEMS |
| K884411 | OPTIMA MPT AND SPT PACEMAKERS | Jan 26, 1989 | Substantially Equivalent | TELECTRONICS, INC. |
| K883037 | UNILITH 3 MODELS 7580/7583/7680/7683 | Jan 25, 1989 | Substantially Equivalent | ELA MEDICAL, INC. |
| K883750 | VENTRALITH I | Jan 13, 1989 | Substantially Equivalent | BIO PACE TECHNOLOGY, INC. |
| K884215 | MINIX 8340, 8341, 8342 MINIX-ST 8330, 8331 | Nov 17, 1988 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K883755 | MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS | Nov 17, 1988 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K882391 | OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024 | Nov 14, 1988 | Substantially Equivalent | ELA MEDICAL, INC. |
| K884023 | MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER | Oct 17, 1988 | Substantially Equivalent | CARDIAC CONTROL SYSTEMS, INC. |
| K882427 | CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066 | Sep 23, 1988 | Substantially Equivalent | ELA MEDICAL, INC. |
| K883087 | PROLOG MP 658M PULSE GENERATOR | Sep 14, 1988 | Substantially Equivalent | PACESETTER SYSTEMS |
| K882476 | OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004 | Sep 12, 1988 | Substantially Equivalent | ELA MEDICAL, INC. |
| K882474 | OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004 | Sep 12, 1988 | Substantially Equivalent | ELA MEDICAL, INC. |
| K881904 | CHANGE TO CATHODE POWDER SPECIFICATION | Jul 22, 1988 | Substantially Equivalent | TELECTRONICS AND CORDIS PACING SYSTEMS |
| K881837 | OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D | Jul 18, 1988 | Substantially Equivalent | TELECTRONICS, INC. |
| K881711 | VICOR MODELS 410B & 410D AND MODIFIED 410A PACEMA. | May 26, 1988 | Substantially Equivalent | TELECTRONICS AND CORDIS PACING SYSTEMS |
| K880898 | MULTICOR AND PACEMAKERS | May 06, 1988 | Substantially Equivalent | TPL-CORDIS, INC. |
| K880326 | MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS | Apr 11, 1988 | Substantially Equivalent | CARDIAC CONTROL SYSTEMS, INC. |
| K880422 | MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER | Mar 31, 1988 | Substantially Equivalent | CARDIAC CONTROL SYSTEMS, INC. |
| K880432 | VICOR PACER, MODEL 410A | Feb 22, 1988 | Substantially Equivalent | TPL-CORDIS, INC. |
| K873158 | MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERS | Jan 07, 1988 | Substantially Equivalent | TPL-CORDIS, INC. |
| K874158 | CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK. | Dec 29, 1987 | Substantially Equivalent | CARDIAC CONTROL SYSTEMS, INC. |
| K874394 | QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA. | Nov 23, 1987 | Substantially Equivalent | INTERMEDICS, INC. |
| K872779 | PROLOG MP PULSE GENERATORS 658K AND 658T | Nov 04, 1987 | Substantially Equivalent | PACESETTER SYSTEMS |
| K872766 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS | Nov 04, 1987 | Substantially Equivalent | TELECTRONICS, INC. |
| K873202 | VICOR, MODEL 410A | Oct 15, 1987 | Substantially Equivalent | TPL-CORDIS, INC. |
| K873528 | MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS | Oct 09, 1987 | Substantially Equivalent | INTERMEDICS, INC. |
| K871992 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS | Aug 12, 1987 | Substantially Equivalent | TELECTRONICS, INC. |
| K871866 | MEDTRONIC CLASSIX MODELS 8436/8437/8438 | Aug 10, 1987 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K871861 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS | Jun 05, 1987 | Substantially Equivalent | TELECTRONICS, INC. |
| K870142 | PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR | Apr 22, 1987 | Substantially Equivalent | CARDIO-PACE MEDICAL, INC. |
| K865013 | ASTRA T2, T4 AND T6 | Feb 19, 1987 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K863898 | MULTILITH 3 MODELS 1350, 3350, 1370, 3370 | Feb 10, 1987 | Substantially Equivalent | ELA MEDICAL, INC. |
| K862226 | DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS | Feb 03, 1987 | Substantially Equivalent | PACESETTER SYSTEMS |
| K860036 | EDP-20 PACEMAKER | Jan 12, 1987 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K862459 | MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE | Jan 02, 1987 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K863879 | NEOS-M VS-1 PULSE GENERATOR | Dec 10, 1986 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K863878 | TRIOS-M VS-1 PULSE GENERATOR | Dec 10, 1986 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K863582 | MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER) | Oct 08, 1986 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K863417 | CORDIS MULTICOR II MODEL 402D PACER | Oct 08, 1986 | Substantially Equivalent | CORDIS CORP. |
| K863365 | MODIFICATION OF STERILITY CYCLE PARAMETERS | Oct 08, 1986 | Substantially Equivalent | CORATOMIC, INC. |
| K863418 | MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE | Sep 24, 1986 | Substantially Equivalent | INTERMEDICS, INC. |
| K862974 | ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN. | Sep 04, 1986 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K854790 | CERYX PACEMAKER MODELS 114, 314 & 614 | Aug 28, 1986 | Substantially Equivalent | VITATRON MEDICAL BV |
| K860921 | NEOS VS-1, PULSE GENERATOR | Aug 08, 1986 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K860922 | MIKROS, MIKROS VS-1, PULSE GENERATOR | Aug 04, 1986 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K860585 | ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR | Jul 16, 1986 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K853771 | PINNACLE MULTI-PROGRAMMABLE PACING SYS | Jul 15, 1986 | Substantially Equivalent | CARDIO-PACE MEDICAL, INC. |
| K861719 | MODIFIED MODELS 8320/8322/8329/8316/8317/8318 | Jul 01, 1986 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K861422 | PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY | Jun 26, 1986 | Substantially Equivalent | PACESETTER SYSTEMS |
| K862071 | MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN | Jun 17, 1986 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K862038 | MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER | Jun 17, 1986 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K862037 | MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN | Jun 17, 1986 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K860573 | IMPLANT PROG PULSE GENERATOR, UNIPOLAR & BIPOLAR | May 28, 1986 | Substantially Equivalent | TELECTRONICS, INC. |
| K861559 | SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS | May 09, 1986 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K861140 | PROGRAMALITH III PULSE GENERATOR | May 02, 1986 | Substantially Equivalent | PACESETTER SYSTEMS |
| K861009 | BIPOLAR CARDIAC PACEMAKER, MODEL 110 | Apr 23, 1986 | Substantially Equivalent | CARDIAC CONTROL SYSTEMS, INC. |
| K852973 | UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762 | Mar 31, 1986 | Substantially Equivalent | ELA MEDICAL, INC. |
| K855147 | MEDTRONIC MODELS 8316,8317,8318 PULSE GENERATORS | Mar 17, 1986 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K855081 | PHOENIX MODELS 250/251 PULSE GENERATORS | Mar 07, 1986 | Substantially Equivalent | PACESETTER SYSTEMS |
| K854482 | ALTERNATE STERILE PKG IMPLANTABLE PULSE GENERATORS | Feb 28, 1986 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K860466 | MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN. | Feb 24, 1986 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K860202 | MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER. | Feb 24, 1986 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K853471 | CCS IMPLANTABLE MAESTRO 106/206/210 CARDIAC PACEMA | Feb 24, 1986 | Substantially Equivalent | CARDIAC CONTROL SYSTEMS, INC. |
| K853400 | CCS IMPLANTABLE MAESTRO SERIES 200 CARDIAC PACEMAK | Feb 24, 1986 | Substantially Equivalent | CARDIAC CONTROL SYSTEMS, INC. |
| K855171 | TELEMETRY WAND MODEL | Jan 22, 1986 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K854560 | IMPLANTABLE PROGRAMMABLE PULSE GENERATOR | Jan 16, 1986 | Substantially Equivalent | TELECTRONICS, INC. |
| K852641 | ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER | Jan 14, 1986 | Substantially Equivalent | SORIN BIOMEDICA, FIAT, USA, INC. |
| K851968 | CORDIS MULTICOR ST, MODEL 350A | Jan 14, 1986 | Substantially Equivalent | CORDIS CORP. |
| K854195 | PROGRAMALITH III MODELS 238 & 239 | Jan 07, 1986 | Substantially Equivalent | PACESETTER SYSTEMS |
| K854919 | BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY | Dec 19, 1985 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K854214 | MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE | Dec 03, 1985 | Substantially Equivalent | CORDIS CORP. |
| K854132 | COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS | Dec 03, 1985 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K851365 | SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM | Dec 03, 1985 | Substantially Equivalent | SORIN BIOMEDICA, FIAT, USA, INC. |
| K852340 | SUPRIMA MODEL 254-24 | Nov 08, 1985 | Substantially Equivalent | INTERMEDICS, INC. |
| K852339 | SUPRIMA MODEL 254-22 | Nov 08, 1985 | Substantially Equivalent | INTERMEDICS, INC. |
| K854143 | BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS | Nov 01, 1985 | Substantially Equivalent | TELECTRONICS, INC. |
| K852748 | CORDIS MODELS 336A,336B,337A & 334 CARDIAC PACEMAK | Nov 01, 1985 | Substantially Equivalent | CORDIS CORP. |
| K852688 | MEDTRONICS MODELS 8320/8322/8329 | Nov 01, 1985 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K853651 | COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER | Oct 23, 1985 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K853590 | COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI | Oct 23, 1985 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K853058 | NEOS - M ABP | Sep 13, 1985 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K853206 | IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW | Sep 12, 1985 | Substantially Equivalent | TELECTRONICS, INC. |
| K853057 | TRIOS - M | Sep 12, 1985 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K853425 | CARIO-PACE DURAPULSE P101 COATED PULSE GENERATOR | Aug 19, 1985 | Substantially Equivalent | CARDIO-PACE MEDICAL, INC. |
| K852435 | CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA | Aug 06, 1985 | Substantially Equivalent | CARDIAC CONTROL SYSTEMS, INC. |
| K853034 | #335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ | Jul 25, 1985 | Substantially Equivalent | INTERMEDICS, INC. |
| K853017 | ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251 | Jul 25, 1985 | Substantially Equivalent | ELA MEDICAL, INC. |
| K852431 | SUPRIMA II MODEL 254-26 | Jul 19, 1985 | Substantially Equivalent | INTERMEDICS, INC. |
| K852432 | SUPRIMA II MODEL 254-28 | Jul 17, 1985 | Substantially Equivalent | INTERMEDICS, INC. |
| K852430 | SUPRIMA II MODEL 253-23 | Jul 17, 1985 | Substantially Equivalent | INTERMEDICS, INC. |
| K851420 | MULTICOR S, MODELS 330A/331A | Jun 21, 1985 | Substantially Equivalent | CORDIS CORP. |
| K844360 | CORDIS MULTICOR S 330A & 331A CARDIAC PACEMAKERS | Jun 18, 1985 | Substantially Equivalent | CORDIS CORP. |
| K851419 | MULTICOR GAMMA 402 SERIES PACER | Jun 11, 1985 | Substantially Equivalent | CORDIS CORP. |
| K851418 | OMNI-ATRICOR MODEL 308A | Jun 11, 1985 | Substantially Equivalent | CORDIS CORP. |
| K851417 | MULTICOR GAMMA MODELS 336/337 | Jun 11, 1985 | Substantially Equivalent | CORDIS CORP. |
| K851416 | STANICOR GAMMA 333B/334A | Jun 11, 1985 | Substantially Equivalent | CORDIS CORP. |
| K851861 | PROGRAMALITH III MODEL 249 PULSE GENERATOR | May 16, 1985 | Substantially Equivalent | PACESETTER SYSTEMS |
| K851699 | COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE | May 16, 1985 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K850464 | PROGRAMALITH III 240 PULSE GENERATOR | May 15, 1985 | Substantially Equivalent | PACESETTER SYSTEMS |
| K844842 | NEOS-LP PULSE GENERATOR | Apr 18, 1985 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K844841 | KALOS-04 PULSE GENERATOR | Apr 18, 1985 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K844812 | NEOS - PULSE GENERATOR | Apr 18, 1985 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K844795 | NEOS-M PULSE GENERATOR | Apr 18, 1985 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K844794 | LEPTOS PULSE GENERATOR | Apr 18, 1985 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K851081 | IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II | Apr 04, 1985 | Substantially Equivalent | TELECTRONICS, INC. |
| K850252 | QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR | Apr 04, 1985 | Substantially Equivalent | TELECTRONICS, INC. |
| K850651 | PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR | Apr 01, 1985 | Substantially Equivalent | PACESETTER SYSTEMS |
| K850384 | CCS IMPLANTABLE MAESTRO SERIES 100-HEART PACEMAKER | Mar 21, 1985 | Substantially Equivalent | CARDIAC CONTROL SYSTEMS, INC. |
| K850656 | COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM | Mar 01, 1985 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K842051 | EKG TRANSMITTER MODEL 5134 | Mar 01, 1985 | Substantially Equivalent | INSTROMEDIX, INC. |
| K844958 | MEDTRONIC MODELS 8432/8433/8434 - PACEMAKER PULSE | Feb 08, 1985 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K844957 | MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR | Feb 08, 1985 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K844793 | SUPRIMA 253-21 IMPLANTABLE PULSE GENERATOR | Feb 08, 1985 | Substantially Equivalent | INTERMEDICS, INC. |
| K844334 | VIVALITH II 301 PULSE GENERATOR | Jan 10, 1985 | Substantially Equivalent | PACESETTER SYSTEMS |
| K842193 | MULTILITH PULSE GENERATORS, 1141 & 2141 | Jan 10, 1985 | Substantially Equivalent | ELA MEDICAL, INC. |
| K841232 | PULSE GENERATOR 696, 696B & 696L | Dec 03, 1984 | Substantially Equivalent | SIEMENS ELEMA AB |
| K841230 | PULSE GENERATOR 686, 686B 686L | Dec 03, 1984 | Substantially Equivalent | SIEMENS ELEMA AB |
| K841225 | PULSE GENERATOR 689, 689B & 689L | Dec 03, 1984 | Substantially Equivalent | SIEMENS ELEMA AB |
| K842220 | MULTILITH 2 PULSE GENERATOR 1141 & 2141 | Nov 29, 1984 | Substantially Equivalent | ELA MEDICAL, INC. |
| K842473 | IMPLANTABLE PROGRAMMABLE PULSE GENERAT | Oct 26, 1984 | Substantially Equivalent | TELECTRONICS, INC. |
| K843837 | MEDTRONIC 5984-5984LP-5985 | Oct 17, 1984 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K842394 | ASTRA 2, ASTRA 3, 4 & 6 | Oct 17, 1984 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K843089 | MEDTRONIC 8437/8438 | Aug 29, 1984 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K841633 | NEOS LP | Aug 06, 1984 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K841635 | LEPTOS | Aug 03, 1984 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K840748 | LITHIUM PACEMAKER 811-811L & 811XL | Aug 03, 1984 | Substantially Equivalent | OMIKRON SCIENTIFIC, LTD. |
| K841983 | COOK PACEMAKER 216 BIPOLAR CARDIAC - | Jul 11, 1984 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K841928 | COOK PACEMAKER 215 UNIPOLAR CARDIAC- | Jul 11, 1984 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K842081 | COOK PACEMAKER CORP. 115 UNIPOLAR CARDI | Jul 06, 1984 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K841233 | PULSE GENERATOR 678L | Jul 06, 1984 | Substantially Equivalent | SIEMENS ELEMA AB |
| K841231 | PULSE GENERATOR 688B & 688L | Jun 26, 1984 | Substantially Equivalent | SIEMENS ELEMA AB |
| K841228 | PULSE GENERATOR 718B & 718L | Jun 26, 1984 | Substantially Equivalent | SIEMENS ELEMA AB |
| K841226 | PULSE GENERATOR 728, 728B & 728L | Jun 26, 1984 | Substantially Equivalent | SIEMENS ELEMA AB |
| K841950 | PULSE GENERATOR KALOS-04 | Jun 25, 1984 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K841636 | NEOS M | Jun 25, 1984 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K841229 | PULSE GENERATOR 698, 698B & 698L | Jun 25, 1984 | Substantially Equivalent | SIEMENS ELEMA AB |
| K841404 | PRIMA 236-02 NONPROGRAMMABLE CARDIAC | May 30, 1984 | Substantially Equivalent | INTERMEDICS, INC. |
| K841075 | CARCIAC PULSE GENERATOR 254-20 | May 16, 1984 | Substantially Equivalent | INTERMEDICS, INC. |
| K841074 | CARDIAC PULSE GENERATOR 254-18 | May 16, 1984 | Substantially Equivalent | INTERMEDICS, INC. |
| K841073 | QUANTUM, UNIPOLAR, MULTI-PROGRAMMABLE | May 16, 1984 | Substantially Equivalent | INTERMEDICS, INC. |
| K840737 | IMPLANTABLE PROGRAMMABLE PULSE GENER | May 16, 1984 | Substantially Equivalent | TELECTRONICS, INC. |
| K840701 | PACEMAKER 147 VVI-THE OPTINIA | May 02, 1984 | Substantially Equivalent | TELECTRONICS, INC. |
| K833428 | IMPLANTABLE UNIPOLAR CARDIAC PULSE GEN | Feb 10, 1984 | Substantially Equivalent | TELECTRONICS, INC. |
| K833427 | IMPLANTABLE BIPOLAR CARDIAC PULSE GEN | Feb 10, 1984 | Substantially Equivalent | TELECTRONICS, INC. |
| K833519 | PULSE GENERATOR MODEL 688 | Jan 30, 1984 | Substantially Equivalent | BURDITT & CALKINS-SIEMENS-ELEMA |
| K834096 | IMPLANTABLE PULSE GENERATOR | Dec 16, 1983 | Substantially Equivalent | INTERMEDICS, INC. |
| K833798 | OPTIMA MDT PULSE GENERATOR W/TELEMETRY | Dec 01, 1983 | Substantially Equivalent | TELECTRONICS, INC. |
| K832914 | PRIMA-UNIPOLAR CARDIAC PULSE GENERAT | Nov 14, 1983 | Substantially Equivalent | INTERMEDICS, INC. |
| K833199 | SILICONE RUBBER ISOLATION SLEEVE 350-01 | Oct 28, 1983 | Substantially Equivalent | INTERMEDICS, INC. |
| K833198 | SILICONE RUBBER ISOLATION SLEEVE 351-01 | Oct 27, 1983 | Substantially Equivalent | INTERMEDICS, INC. |
| K831860 | GENERATOR, PULSE, PACEMAKER #532 | Oct 27, 1983 | Substantially Equivalent | VITATRON MEDICAL BV |
| K831859 | PACEMAKER PROGRAMMER #2032 | Oct 27, 1983 | Substantially Equivalent | VITATRON MEDICAL BV |
| K831633 | QUANTUM BIPOLAR CARDIAC PULSE GENERATOR | Oct 12, 1983 | Substantially Equivalent | INTERMEDICS, INC. |
| K832893 | MODEL 329T PROGRAMMABLE, BIPOLAR CARDI | Oct 04, 1983 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K831771 | IMPLANTABLE PROGRAM. CARDIAC PULSE GEN | Aug 16, 1983 | Substantially Equivalent | TELECTRONICS, INC. |
| K832052 | MODEL 327T UNIPOLAR CARDIAC PULSE GEN | Aug 08, 1983 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K831216 | COMMAND ULTRA II | Jul 12, 1983 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K831161 | COMMAND ULTRA I | Jun 15, 1983 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K830344 | SIEMENS-ELMA PULSE GENERATOR #718 | May 27, 1983 | Substantially Equivalent | BURDITT & CALKINS-SIEMENS-ELEMA |
| K830862 | NEDS-01 & EPR-500 | May 25, 1983 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K830390 | IMPLANTABLE BIPOLAR CARDIAC PULSE GEN | Mar 24, 1983 | Substantially Equivalent | TELECTRONICS, INC. |
| K823878 | IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242 | Mar 24, 1983 | Substantially Equivalent | PACESETTER SYSTEMS |
| K830401 | UNILITH PULSE GENERATOR VVI #7542 | Mar 17, 1983 | Substantially Equivalent | ELA MEDICAL, INC. |
| K830382 | COMMAND ULTRA II | Mar 17, 1983 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K823831 | MEDTRONIC MODELS 59401 5941 | Mar 16, 1983 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K823863 | CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC | Mar 10, 1983 | Substantially Equivalent | INTERMEDICS, INC. |
| K823559 | AFP PULSE GENERATOR | Feb 18, 1983 | Substantially Equivalent | PACESETTER SYSTEMS |
| K822639 | AFP SYSTEM PULSE GENERATOR MODEL 261/262 | Feb 18, 1983 | Substantially Equivalent | PACESETTER SYSTEMS |
| K823678 | TELEMETRY DECODER #540-02 | Dec 22, 1982 | Substantially Equivalent | INTERMEDICS, INC. |
| K823371 | DURAPULSE | Dec 22, 1982 | Substantially Equivalent | CPM INTERNATIONAL, INC. |
| K822791 | CORATOMIC #VX5-105 & VX5-205 PULSE GEN. | Dec 15, 1982 | Substantially Equivalent | CORATOMIC, INC. |
| K822907 | KALOS-03 BIPOLAR | Nov 01, 1982 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K822904 | MODEL 325D UNIPOLAR CARDIAC PULSE GEN | Oct 15, 1982 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K822652 | JAIN INSULATING BOOT MODEL 225B | Oct 04, 1982 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K822309 | COMMAND NP | Oct 04, 1982 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K822297 | ENERTRAX MODEL 7100E | Oct 04, 1982 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K822147 | MEDTRONIC ENERTRAX MODEL 7100 | Aug 06, 1982 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K820939 | C-101-P | Jun 22, 1982 | Substantially Equivalent | CORATOMIC, INC. |
| K821033 | CORATOMIC MODEL OVALITH-920 | May 28, 1982 | Substantially Equivalent | CORATOMIC, INC. |
| K821014 | CORATOMIC MODEL OVALITH 920BP | May 28, 1982 | Substantially Equivalent | CORATOMIC, INC. |
| K821147 | COOK #326T PROGRAM/TELEMETRY BIPOLAR | May 07, 1982 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K821073 | PULSE GENERATOR | May 07, 1982 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K821003 | PROGRAMMALITH II, #225 & 226 | May 07, 1982 | Substantially Equivalent | PACESETTER SYSTEMS |
| K820657 | PULSE GENERATOR 678 B | Apr 15, 1982 | Substantially Equivalent | SIEMENS ELEMA AB |
| K820853 | QUANTUM MODELS 253-09, 254-09 254-10 | Apr 09, 1982 | Substantially Equivalent | INTERMEDICS, INC. |
| K820774 | IMPLANTABLE, MULTIPROGRAMMABLE | Apr 09, 1982 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K820356 | MULTICOR (GAMMA) 402 CARDIAC PACER | Mar 18, 1982 | Substantially Equivalent | CORDIS CORP. |
| K820231 | COMMAND ULTRA I | Mar 15, 1982 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K813246 | MEDICAL MULTILITH PULSE GENERA-1140 | Feb 12, 1982 | Substantially Equivalent | ELA MEDICAL, INC. |
| K813576 | SIEMENS-ELEMA PULSE GENERATOR 659 | Jan 22, 1982 | Substantially Equivalent | SIEMENS ELEMA AB |
| K813534 | COMMAND P5 | Jan 22, 1982 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K813079 | BIPOLAR OPTIMA MP #255 | Dec 10, 1981 | Substantially Equivalent | TELECTRONICS, INC. |
| K812610 | SIEMENS-ELEMA PULSE GENERATOR 668 B | Dec 10, 1981 | Substantially Equivalent | SIEMENS CORP. |
| K813150 | DIRECTIONAL BOOT | Dec 02, 1981 | Substantially Equivalent | PACESETTER SYSTEMS |
| K813101 | CARDIOBEEPER MEMORY MONITOR | Nov 27, 1981 | Substantially Equivalent | SURVIVAL TECHNOLOGY, INC. |
| K812464 | SYNTHEMED PULSE GENERATOR VVI MODEL 1000 | Nov 16, 1981 | Substantially Equivalent | SYNTHEMED CORP. |
| K812832 | MODEL 325C UNIPOLAR CARDIAC PULSE GEN. | Nov 05, 1981 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K812790 | IMPLANTABLE VENTRICULAR-INHIBITED CARDI | Oct 29, 1981 | Substantially Equivalent | TELECTRONICS, INC. |
| K812358 | MODEL 325T PROGRAMMABLE PULSE GENERATOR | Oct 29, 1981 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K812218 | KALOS-03 | Oct 13, 1981 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K812580 | MEDTRONIC MODEL 2409 | Sep 23, 1981 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K801339 | TELEMETRY DECODER | Sep 23, 1981 | Substantially Equivalent | INTERMEDICS, INC. |
| K801337 | CYBERLITH IX IMPLANTABLE PULSE GENERATOR | Sep 23, 1981 | Substantially Equivalent | INTERMEDICS, INC. |
| K812096 | MEDTRONIC ENERTRAX MODEL 7100 | Sep 16, 1981 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K812153 | MEDTRONIC SPECTRAX | Aug 31, 1981 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K811402 | COMMAND P5(BIPOLAR PULSE GENERATOR) | Jul 27, 1981 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K811768 | CORATOMIC MODEL OVALITH-920BP | Jul 20, 1981 | Substantially Equivalent | CORPTOMIC |
| K811691 | CORDIS OMNI-ARTICOR CARDIAC PACER #308 | Jul 20, 1981 | Substantially Equivalent | CORDIS CORP. |
| K810887 | ELA MEDICAL UNILITH 7540 PULSE GENERATOR | Jul 20, 1981 | Substantially Equivalent | ELA MEDICAL, INC. |
| K811350 | UNIPOLAR SPECTRAX IMPL. PULSE GENERAT. | Jul 01, 1981 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K810885 | #326 PROGRAMMABLE CARD. PULSE GENERATOR | Jun 16, 1981 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K810884 | #325 PROGRAMMABLE CARD. PULSE GENERATOR | Jun 16, 1981 | Substantially Equivalent | COOK PACEMAKER CORP. |
| K810489 | MULTILITH PULSE GENERATOR #1140 | May 29, 1981 | Substantially Equivalent | ELA MEDICAL, INC. |
| K810142 | ELA MEDICAL UNILITH PULSE GENERATOR | May 29, 1981 | Substantially Equivalent | ELA MEDICAL, INC. |
| K811221 | INTERMEDICS CYBERLITH BIPOLAR CARDIAC | May 27, 1981 | Substantially Equivalent | INTERMEDICS, INC. |
| K811123 | MEDTRONIC PULSE GENERATOR | May 27, 1981 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K810677 | MODELS 5976/5977 PACEMAKER PULSE GENER | May 27, 1981 | Substantially Equivalent | MEDTRONIC INC. |
| K810808 | CORATOMIC MODEL OVALITH-920 | May 15, 1981 | Substantially Equivalent | CORATOMIC, INC. |
| K810734 | MODELS 8420 THRU 8423 PACEMAKER GENER | May 15, 1981 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K811066 | MODEL 230-06 CYBERLITH TM I BIPOLAR IN | May 01, 1981 | Substantially Equivalent | INTERMEDICS, INC. |
| K810800 | MODEL 230-05 CYBERLITH I BIPOL. PULSE G. | May 01, 1981 | Substantially Equivalent | INTERMEDICS, INC. |
| K810752 | THINLITH III UNIPOLAR CARDIAC PULSE GEN. | May 01, 1981 | Substantially Equivalent | INTERMEDICS, INC. |
| K810901 | INSULATIVE COATING FOR CARD. PULSE GEN | Apr 14, 1981 | Substantially Equivalent | INTERMEDICS, INC. |
| K810603 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE | Apr 14, 1981 | Substantially Equivalent | TELECTRONICS, INC. |
| K810385 | CYBERLITH I PULSE GENERATOR MODEL 253-04 | Apr 01, 1981 | Substantially Equivalent | INTERMEDICS, INC. |
| K810383 | INTERMEDICS CYBERLITH I BIOPOLAR CARDI | Apr 01, 1981 | Substantially Equivalent | INTERMEDICS, INC. |
| K810386 | THINLITH II PULSE GNEERATOR MODEL 227-05 | Mar 13, 1981 | Substantially Equivalent | INTERMEDICS, INC. |
| K810410 | STERILE PACKAGING | Mar 05, 1981 | Substantially Equivalent | TELECTRONICS, INC. |
| K810121 | UNIFOCAL 3 | Feb 23, 1981 | Substantially Equivalent | AMERICAN PACEMAKER CORP. |
| K801584 | MULTI-PROGRAMMABLE PACEMAKER & PROGRMR. | Feb 12, 1981 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K802864 | SIEMENS-ELEMA PULSE GENERATOR 678 | Feb 05, 1981 | Substantially Equivalent | SIEMENS ELEMA AB |
| K810036 | SIEMENS-ELEMA MYOCARDIAL LEAD | Jan 29, 1981 | Substantially Equivalent | SIEMENS ELEMA AB |
| K803197 | IMPL. PROGRAMMABLE BIPOLAR CARD.GEN.#274 | Jan 22, 1981 | Substantially Equivalent | TELECTRONICS, INC. |
| K801338 | CYBERLITH PROGRAMMER | Jan 07, 1981 | Substantially Equivalent | INTERMEDICS, INC. |
| K803035 | MICROTHIN-PII BIPOLAR PULSE GEN. #0621 | Dec 22, 1980 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K803034 | MICROTHIN-PII BIPOLAR PULSE GEN. #0623 | Dec 22, 1980 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K802353 | MICRO THIN-PII, #0523 | Dec 22, 1980 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K802352 | MICRO THIN-DII, #0521 | Dec 22, 1980 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K800746 | UNIFOCAL VP, MODELS 7501 AND 7502 | Dec 16, 1980 | Substantially Equivalent | AMERICAN PACEMAKER CORP. |
| K801324 | SIEMENS-ELEMA PULSE GENERATOR 668 | Dec 01, 1980 | Substantially Equivalent | SIEMENS ELEMA AB |
| K802588 | MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN. | Nov 19, 1980 | Substantially Equivalent | ARCO MEDICAL PRODUCTS CO. |
| K792609 | LITHICRON 0520 P-SYNCHRONEOUS PULSE GEN. | Nov 19, 1980 | Substantially Equivalent | MEDCOR, INC. |
| K802410 | MICROTHIN-PI BIPOLAR PULSE GENERATOR | Oct 31, 1980 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K802409 | MICROTHIN-DI BIPOLAR PULSE GENERATOR | Oct 31, 1980 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K801640 | SORIN PULSE GENERATOR, MODEL #LIT-214 | Oct 03, 1980 | Substantially Equivalent | BENTLEY LABORATORIES, INC. |
| K802028 | IMPLANTABLE VENTRICULAR-INHIB. C.P. GEN | Sep 26, 1980 | Substantially Equivalent | TELECTRONICS, INC. |
| K801978 | PROGRAMALITH #'S 221, 222, 221A & 222A | Sep 26, 1980 | Substantially Equivalent | PACESETTER SYSTEMS |
| K800379 | BIFOCAL 2 8200 SERIES (A,B C,D) | Sep 26, 1980 | Substantially Equivalent | AMERICAN PACEMAKER CORP. |
| K800793 | IMPLANTABLE PROGRAM. CARDIAC PACEMAKER | Sep 18, 1980 | Substantially Equivalent | TELECTRONICS, INC. |
| K801508 | SIEMENS-ELEMA PULSE GENERATOR 625 | Sep 16, 1980 | Substantially Equivalent | SIEMENS ELEMA AB |
| K802040 | BATTERY FOR #229-01 PULSE GENERATOR | Sep 09, 1980 | Substantially Equivalent | INTERMEDICS, INC. |
| K801910 | INSULATING SHEATH | Sep 09, 1980 | Substantially Equivalent | CORDIS CORP. |
| K801806 | EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE | Sep 09, 1980 | Substantially Equivalent | ARCO MEDICAL PRODUCTS CO. |
| K800226 | MEDTRONIC MODEL 2409 | Sep 09, 1980 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K801763 | VIVALITH 5, - MDL-201A & TDL-201A | Aug 27, 1980 | Substantially Equivalent | PACESETTER SYSTEMS |
| K801647 | SONACOLOR 6100 | Aug 20, 1980 | Substantially Equivalent | CAROLINA MEDICAL ELECTRONICS |
| K801450 | INTERMEDICS THIN LITH IV SERIES UNIPOLAR | Aug 14, 1980 | Substantially Equivalent | INTERMEDICS, INC. |
| K801106 | MULTICOR (GAMMA) MODEL 336 & MODEL 337 | Jul 08, 1980 | Substantially Equivalent | CORDIS CORP. |
| K801241 | UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN. | Jun 30, 1980 | Substantially Equivalent | ARCO MEDICAL PRODUCTS CO. |
| K801122 | MICROTHIN-D1 (MOD. 0620) | Jun 30, 1980 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K801121 | MICROTHIN-P1 (MOD. 0622) | Jun 30, 1980 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K800837 | PROGRAMMABLE BIPOLAR CARDIAC GENERATOR | Jun 30, 1980 | Substantially Equivalent | ARCO MEDICAL PRODUCTS CO. |
| K800069 | MEDTRONIC MODELS 5966/5967, ETC. | Jun 26, 1980 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K800838 | ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. | Jun 04, 1980 | Substantially Equivalent | ARCO MEDICAL PRODUCTS CO. |
| K800285 | MODEL 5985 PACEMAKER PULSE GENERATOR | May 20, 1980 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K800387 | PULSE GENERATORS MODELS 657 & 677 | May 02, 1980 | Substantially Equivalent | SIEMENS ELEMA AB |
| K800895 | MODEL 253-11 CYBERLITH PULSE GENERATOR | Apr 24, 1980 | Substantially Equivalent | INTERMEDICS, INC. |
| K800644 | CYBERLITH IMPLANTABLE PULSE GEN. #253-02 | Apr 16, 1980 | Substantially Equivalent | INTERMEDICS, INC. |
| K800375 | NOMOS-01 PULSE GENERATOR | Apr 16, 1980 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K800645 | CYBERLITH IMPLANTABLE PULSE GEN. #253-04 | Apr 08, 1980 | Substantially Equivalent | INTERMEDICS, INC. |
| K800573 | IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC | Mar 25, 1980 | Substantially Equivalent | TELECTRONICS, INC. |
| K800326 | ARCOLITH 3021-CARDIAC PULSE GENERATOR | Mar 17, 1980 | Substantially Equivalent | ARCO MEDICAL PRODUCTS CO. |
| K800194 | OVALITH P-BP BIPOLAR CARDIAC PACEMAKER | Feb 11, 1980 | Substantially Equivalent | CORATOMIC, INC. |
| K792565 | SORIN PULSE GENERATOR MODEL # LIT 214 H | Feb 05, 1980 | Substantially Equivalent | BENTLEY LABORATORIES, INC. |
| K792526 | PULSE GENERATOR, MODEL NO. LIT 222 | Feb 05, 1980 | Substantially Equivalent | BENTLEY LABORATORIES, INC. |
| K800027 | MICROTHIN-PI | Jan 31, 1980 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K800026 | MICROTHIN-DI | Jan 31, 1980 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K800030 | IMPLANTABLE BIPOLAR CARDIAC PULSE GEN. | Jan 11, 1980 | Substantially Equivalent | TELECTRONICS, INC. |
| K792519 | IMPLANTABLE PROGRAMMABLE UNIPOLAR | Dec 20, 1979 | Substantially Equivalent | TELECTRONICS, INC. |
| K792299 | ARCOLITH 3020-CARDIAC PULSE GENERATOR | Nov 29, 1979 | Substantially Equivalent | ARCO MEDICAL PRODUCTS CO. |
| K792216 | ARCOLITH 2100-CARDIAC PULSE GENERATOR | Nov 29, 1979 | Substantially Equivalent | ARCO MEDICAL PRODUCTS CO. |
| K791920 | CARDIAC PACEMAKER P4000 SER. & P1000 | Nov 29, 1979 | Substantially Equivalent | VITATRON MEDICAL BV |
| K792232 | UNIFOCAL 3-2 MODELS UNIPOLAR & BIPOLAR | Nov 27, 1979 | Substantially Equivalent | AMERICAN PACEMAKER CORP. |
| K792199 | UNIFOCAL 2-UNIPOLAR & BIPOLAR | Nov 27, 1979 | Substantially Equivalent | AMERICAN PACEMAKER CORP. |
| K791955 | UNIFOCAL 1 UNIPOLAR DEMAND R WAVE | Nov 27, 1979 | Substantially Equivalent | AMERICAN PACEMAKER CORP. |
| K791316 | MEDTRONIC MODELS 5984/5985 | Nov 15, 1979 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K791921 | CARDIAC PACEMAKER C4000, C1000 SER. | Oct 26, 1979 | Substantially Equivalent | VITATRON MEDICAL BV |
| K792052 | IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD | Oct 22, 1979 | Substantially Equivalent | TELECTRONICS, INC. |
| K791783 | OMNI-STANICOR (THETA) MOD 237A | Oct 22, 1979 | Substantially Equivalent | CORDIS CORP. |
| K790792 | PULSE GENERATOR MODEL 637 | Oct 12, 1979 | Substantially Equivalent | ELEMA-SCHONANDER, INC. |
| K791784 | CORDIS BIPOLAR PACER CONNECTOR SYSTEM | Sep 28, 1979 | Substantially Equivalent | CORDIS CORP. |
| K790068 | PULSE GENERATORS, MODELS 5983, 5989 | Sep 28, 1979 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K791727 | IMPLANTABLE VENTRICULAR-INHIBITED | Sep 27, 1979 | Substantially Equivalent | TELECTRONICS, INC. |
| K791715 | ARCOLITH 2000 | Sep 27, 1979 | Substantially Equivalent | ARCO MEDICAL PRODUCTS CO. |
| K791751 | EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR | Sep 26, 1979 | Substantially Equivalent | EDWARDS PACEMAKER SYSTEMS |
| K791181 | PROGRAMMER, MEDTRONIC MODEL 5984/5985 | Sep 20, 1979 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K790873 | MODEL 221 PROGRAMALITH PULSE GENERATOR | Sep 20, 1979 | Substantially Equivalent | PACESETTER SYSTEMS |
| K791568 | IMPLANTABLE PULSE GENERATOR PACEMAKERS | Sep 19, 1979 | Substantially Equivalent | INTERMEDICS, INC. |
| K791379 | MODEL 228-02 THINLITH II PACEMAKER, BIPO | Sep 12, 1979 | Substantially Equivalent | INTERMEDICS, INC. |
| K791678 | LITHICRON II 0403 IMPLANTABLE PACEMAKER | Sep 07, 1979 | Substantially Equivalent | MEDCOR, INC. |
| K791417 | IMPLANTABLE PULSE GENERATOR PACEMAKER | Sep 04, 1979 | Substantially Equivalent | INTERMEDICS, INC. |
| K791225 | BJORK-SHILEY AORTIC GRAFT VALVE PROSTH | Aug 10, 1979 | Substantially Equivalent | SHILEY, INC. |
| K791095 | LITHICRON MODEL 0401, PACEMAKER | Aug 10, 1979 | Substantially Equivalent | MEDCOR, INC. |
| K790428 | MDL-201A & T DL-201A PULSE GENERATOR | Aug 10, 1979 | Substantially Equivalent | PACESETTER SYSTEMS |
| K790141 | PULSE GENERATOR, R WAVE DEMAND | Aug 10, 1979 | Substantially Equivalent | PACESETTER SYSTEMS |
| K791147 | ARCO PROGAMMABLE PACEMAKER SYSTEM | Aug 03, 1979 | Substantially Equivalent | ARCO MEDICAL PRODUCTS CO. |
| K791219 | UNILITH PULSE GENERATOR | Jul 30, 1979 | Substantially Equivalent | ELA MEDICAL, INC. |
| K790446 | OVALITH-300 | Jul 30, 1979 | Substantially Equivalent | CORATOMIC, INC. |
| K782162 | BATTERY CHARGER, 171 PACEMAKER | Jul 24, 1979 | Substantially Equivalent | TELECTRONICS, INC. |
| K782161 | PULSE GENERATOR, MODEL 171 | Jul 24, 1979 | Substantially Equivalent | TELECTRONICS, INC. |
| K791165 | ARCOLITH 4000 | Jul 10, 1979 | Substantially Equivalent | ARCO MEDICAL PRODUCTS CO. |
| K790670 | PULSE GENERATOR MODEL 629 | Jun 27, 1979 | Substantially Equivalent | ELEMA-SCHONANDER, INC. |
| K791093 | MODELS 2411/2418 VENTRICULAR-INHIBITED | Jun 20, 1979 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K790666 | VITALITH S 3000 SERIES | Jun 01, 1979 | Substantially Equivalent | VITATRON MEDICAL BV |
| K790867 | CARDIAC PULSE GENERATOR, 16 SERIES | May 31, 1979 | Substantially Equivalent | TELECTRONICS, INC. |
| K790868 | GENERATOR, 16 SERIES, MODIFIED TOP CAP | May 25, 1979 | Substantially Equivalent | TELECTRONICS, INC. |
| K790690 | OMNI-STANICOR-(THETA) MODEL 217 | May 16, 1979 | Substantially Equivalent | CORDIS CORP. |
| K790562 | PULSE GENERATOR MODEL 61 AND 128 | May 08, 1979 | Substantially Equivalent | ELA MEDICAL, INC. |
| K790452 | 28 UNIPOLAR AND BIPOLAR PULSE GENERATORS | May 08, 1979 | Substantially Equivalent | EDWARDS PACEMAKER SYSTEMS |
| K790764 | PACEMAKERS WITHOUT SILASTIC COATING | Apr 26, 1979 | Substantially Equivalent | TELECTRONICS, INC. |
| K781973 | CARDIOPHONE | Mar 21, 1979 | Substantially Equivalent | NORTH AMERICAN MOTRONIC |
| K790432 | MICROLITH MODELS 505;605;507;607;703;803 | Mar 20, 1979 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K790566 | PACEMAKER, OVALITH-D CARDIAC | Mar 19, 1979 | Unknown | CARATOMIC |
| K790276 | MINILITH AND MICROLITH | Feb 26, 1979 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K790014 | BIPOLAR, STANICOR LAMBDA MODEL 236,235 | Feb 08, 1979 | Substantially Equivalent | CORDIS CORP. |
| K782149 | PULSE GENERATOR, IMPLANTABLE CARDIAC | Feb 08, 1979 | Substantially Equivalent | TELECTRONICS, INC. |
| K790101 | ISOLATION SLEEVE, MODEL 346-01 | Jan 24, 1979 | Substantially Equivalent | INTERMEDICS, INC. |
| K790100 | ISOLATION SLEEVE, MODEL 348-01 | Jan 24, 1979 | Substantially Equivalent | INTERMEDICS, INC. |
| K790099 | ISOLATION SLEEVE, MODEL 347-01 | Jan 24, 1979 | Substantially Equivalent | INTERMEDICS, INC. |
| K790098 | ISOLATION SLEEVE, MODEL 349-01 | Jan 24, 1979 | Substantially Equivalent | INTERMEDICS, INC. |
| K782146 | PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT | Dec 27, 1978 | Unknown | ARCO MEDICAL PRODUCTS CO. |
| K782023 | MICROLITH A MODEL 803 | Dec 22, 1978 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K782022 | MICROLITH A MODEL 703 | Dec 22, 1978 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K780430 | LITHICRON F PROGRAMMABLE PULSE GEN | Dec 22, 1978 | Substantially Equivalent | MEDCOR, INC. |
| K781835 | PULSTRON MODEL 100 | Dec 21, 1978 | Substantially Equivalent | MICRO-REL |
| K781738 | PACEMAKER, MODEL 229-01 | Dec 07, 1978 | Substantially Equivalent | INTERMEDICS, INC. |
| K780897 | GENERATOR, PULSE, SORIN MODEL DL-1 | Dec 06, 1978 | Substantially Equivalent | BENTLEY LABORATORIES, INC. |
| K781377 | OVALITH 10BP | Dec 04, 1978 | Substantially Equivalent | CORATOMIC, INC. |
| K781252 | GENERATOR, PULSE, MODEL 5997 | Oct 03, 1978 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K781208 | GENERATORS, PULSE, MODELS 5988/5989 | Oct 03, 1978 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K780776 | ARCOBIOLITH PACEMAKER MODEL | Oct 03, 1978 | Substantially Equivalent | ARCO MEDICAL PRODUCTS CO. |
| K781424 | GENERATORS: UDL-201B, BDL-201B, MDL-201B | Sep 27, 1978 | Substantially Equivalent | PACESETTER SYSTEMS |
| K780940 | GENERATOR, PULSE, MODEL 160B | Sep 27, 1978 | Substantially Equivalent | TELECTRONICS, INC. |
| K772226 | PACEMAKER, MODEL 225 & 227 | Sep 27, 1978 | Substantially Equivalent | INTERMEDICS, INC. |
| K781426 | CARDIAL PULSE GENERATORS | Sep 07, 1978 | Substantially Equivalent | TELECTRONICS, INC. |
| K781178 | PULSE GENERATOR MODEL 208 | Sep 07, 1978 | Substantially Equivalent | ELEMA-SCHONANDER, INC. |
| K781090 | GENERATOR, CARDIAC PULSE, 250B | Sep 07, 1978 | Substantially Equivalent | TELECTRONICS, INC. |
| K781168 | GENERATOR, PULSE, PACEMAKER | Aug 31, 1978 | Substantially Equivalent | VITATRON MEDICAL BV |
| K780809 | GENERATOR, PULSE MODELS 5920/5921 | Jul 28, 1978 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K780741 | GENERATOR, PULSE, DEMAND, MODEL 5996 | Jul 28, 1978 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K781042 | PROLITH 23S PACEMAKER | Jul 27, 1978 | Substantially Equivalent | EDWARDS PACEMAKER SYSTEMS |
| K780781 | STILITH CARDIAC PACEMAKERS-M. 60 & 120 | Jul 27, 1978 | Substantially Equivalent | R.E. BROWN CO., INC. |
| K780561 | VENTRICULAR INHIBITED PULSE GENERATOR | Jul 27, 1978 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K780420 | GENERATOR, PULSE, CARDIAC, IMPLANTABLE | Jul 27, 1978 | Substantially Equivalent | TELECTRONICS, INC. |
| K780421 | GENERATOR, PULSE, CARDIAC, IMPLANTABLE | Jul 07, 1978 | Substantially Equivalent | TELECTRONICS, INC. |
| K780780 | MICROPULSE 22S PACEMAKER | Jun 30, 1978 | Substantially Equivalent | EDWARDS PACEMAKER SYSTEMS |
| K780453 | STANICOR THETA MODEL 221 CARDIAC PACER | Jun 30, 1978 | Substantially Equivalent | CORDIS CORP. |
| K780327 | GENERATORS, ATRIAL INHIBITED PULSE | May 18, 1978 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K780777 | BAGS, PLASTIC, STERILE FOR GENERATORS | May 16, 1978 | Substantially Equivalent | TELECTRONICS, INC. |
| K780437 | PACEMAKER, MODEL 252, C-MOS | Apr 05, 1978 | Substantially Equivalent | INTERMEDICS, INC. |
| K780238 | PACEMAKER, PROLITH 23U. PULSE GENERATOR | Mar 15, 1978 | Substantially Equivalent | EDWARDS PACEMAKER SYSTEMS |
| K780113 | CARDIAC PULSE GENERATOR, MODEL 160B | Feb 13, 1978 | Substantially Equivalent | TELECTRONICS, INC. |
| K780091 | MICROPULSE 22U | Jan 30, 1978 | Substantially Equivalent | EDWARDS PACEMAKER SYSTEMS |
| K780066 | CARDIAC PACER, MODEL 208 | Jan 30, 1978 | Substantially Equivalent | CORDIS CORP. |
| K772241 | PULSE GENERATOR, BIPOLAR, DEMAND | Jan 30, 1978 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K772240 | PULSE GENERATOR, UNIPOLAR, DEMAND | Jan 30, 1978 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K772239 | PULSE GENERATOR, BIPOLAR, PROGRAMMABLE | Jan 30, 1978 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K772238 | PULSE GENERATOR, UNIPOLAR, PROGRAMABLE | Jan 30, 1978 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K772051 | MDL-201 | Jan 30, 1978 | Substantially Equivalent | PACESETTER SYSTEMS |
| K772050 | TDL-100 B | Jan 30, 1978 | Substantially Equivalent | PACESETTER SYSTEMS |
| K780061 | PULSE GENERATORS, MODELS 5972/5973 | Jan 24, 1978 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K772357 | PULSE GENERATORS | Jan 17, 1978 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K771786 | CARDIAC PULSE GENERATORS 5982/5983 | Jan 04, 1978 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K771770 | XYREL-RA MODELS 5994/5995 | Jan 04, 1978 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K772202 | PULSE GENERATOR, A-V SEQ. | Dec 20, 1977 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K772010 | CARDIAC PACEMAKER C2001 | Nov 28, 1977 | Substantially Equivalent | VITATRON MEDICAL BV |
| K772009 | CARDIAC PACEMAKER S6001 | Nov 28, 1977 | Substantially Equivalent | VITATRON MEDICAL BV |
| K772057 | BIPOLAR PACEMAKER MODEL 224 | Nov 03, 1977 | Substantially Equivalent | INTERMEDICS, INC. |
| K772026 | CARDIAC PULSE GENERATOR, MODEL 150L | Nov 03, 1977 | Substantially Equivalent | TELECTRONICS, INC. |
| K771992 | L-501 CARDIAC PACEMAKER | Nov 02, 1977 | Substantially Equivalent | CORATOMIC, INC. |
| K771987 | MICROPULSE 26U PULSE GENERATOR | Nov 02, 1977 | Substantially Equivalent | EDWARDS PACEMAKER SYSTEMS |
| K771670 | IMPLANTED PACEMAKER PLUSE GENERATOR | Sep 12, 1977 | Substantially Equivalent | TELECTRONICS, INC. |
| K771626 | PACEMAKER MODEL 251 | Sep 12, 1977 | Substantially Equivalent | INTERMEDICS, INC. |
| K771538 | LITHICRON MODEL 3-70C-B PULSE GENERATOR | Aug 22, 1977 | Substantially Equivalent | MEDCOR, INC. |
| K771262 | PACEMAKER & CARDIAC LEAD, BIPOLAR | Jul 21, 1977 | Substantially Equivalent | ARCO MEDICAL PRODUCTS CO. |
| K770951 | CARDIAC PACERS W/NARROW PULSE WIDTH | Jun 20, 1977 | Substantially Equivalent | CORDIS CORP. |
| K770881 | GENERATOR, PULSE, BIPOLAR 3608 | Jun 20, 1977 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K770880 | GENERATOR, PULSE, UNIPOLAR, #508 | Jun 20, 1977 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K770716 | GENERATOR, PULSE, UNIPOLAR, MODEL #504 | Apr 26, 1977 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K770661 | GENERATOR, PULSE, IMPLANTABLE | Apr 26, 1977 | Substantially Equivalent | MED TELECTRONICS LTD. |
| K770657 | GENERATOR, PULSE, CARDIAC 2LU | Apr 26, 1977 | Substantially Equivalent | EDWARDS PACEMAKER SYSTEMS |
| K770656 | GENERATOR, PULSE, CARDIAC 20U | Apr 26, 1977 | Substantially Equivalent | EDWARDS PACEMAKER SYSTEMS |
| K770715 | GENERATOR, PULSE, BIPOLAR, MODEL #604 | Apr 25, 1977 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K770507 | PULSE GENERATOR, LITKICRON MODEL 3-70H | Apr 07, 1977 | Substantially Equivalent | MEDCOR, INC. |
| K770419 | CENTURION | Apr 05, 1977 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K770559 | C-L0L CARDIAC PACEMAKER | Mar 28, 1977 | Substantially Equivalent | CORATOMIC, INC. |
| K770212 | PROLITH MODEL 21S CARDIAC PULSE GEN. | Mar 09, 1977 | Substantially Equivalent | EDWARDS PACEMAKER SYSTEMS |
| K770211 | MICROPULSE MODEL 20S | Mar 07, 1977 | Substantially Equivalent | EDWARDS PACEMAKER SYSTEMS |
| K770328 | PACEMAKER, ANTRIO-VENTRICULAR SEQ. | Feb 28, 1977 | Substantially Equivalent | AMERICAN PACEMAKER CORP. |
| K770005 | PACEMAKER 208S | Feb 24, 1977 | Substantially Equivalent | ELEMA-SCHONANDER, INC. |
| K770198 | BIPOLAR ASYNCHRONOUS PULSE GENERATOR | Feb 07, 1977 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K770197 | UNIPOLAR, ASYNCHRONOUS PULSE GENERATOR | Feb 07, 1977 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K770135 | LEAD MODIFICATION | Feb 07, 1977 | Substantially Equivalent | ELEMA-SCHONANDER, INC. |
| K761143 | LITHIUM IODIDE BATTERY PACEMAKER (#201) | Dec 23, 1976 | Substantially Equivalent | PACESETTER SYSTEMS |
| K761237 | ELEC. CIR. PACE. MO. LI-2,LI-3,LI-4,LI-5 | Dec 21, 1976 | Substantially Equivalent | ARCO MEDICAL PRODUCTS CO. |
| K760671 | PACEMAKERS, VITATRONS (SERIES 3000) | Nov 12, 1976 | Substantially Equivalent | VITATRON MEDICAL BV |
| K760670 | PACEMAKERS, VITATRONS (SERIES 2000) | Nov 12, 1976 | Substantially Equivalent | VITATRON MEDICAL BV |
| K760669 | PACEMAKERS, VITATRON'S | Nov 12, 1976 | Substantially Equivalent | VITATRON MEDICAL BV |
| K760757 | MODEL 100 CARDIAC PACEMAKER | Nov 11, 1976 | Substantially Equivalent | PACESETTER SYSTEMS |
FEI Numbers
This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.