Product Code: GZB
FDA class 2
21 CFR 882.5880
Stimulator, Spinal-Cord, Implanted (Pain Relief)
Neurology
The Implanted Spinal Cord Stimulator for Pain Relief is a surgically implanted neuromodulation device that delivers continuous or programmed electrical impulses to the spinal cord to reduce chronic pain conditions such as failed back surgery syndrome, complex regional pain syndrome, and neuropathic pain. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification, and is designated as an implant. The product code is GZB under regulation 21 CFR 882.5880 in the Neurology specialty. The implant flag is active for this device.
510(k)s
139
FEI Numbers
33
Registration Numbers
33
Unique Applicants
26
Years Active
47
Basic Information
- Product Code
- GZB
- Device Class
- FDA class 2
- Regulation Number
- 882.5880
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
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 139 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation | Aug 23, 2024 | Substantially Equivalent | Nalu Medical Inc. |
| K221376 | Nalu Neurostimulation System | Jun 10, 2022 | Substantially Equivalent | Nalu Medical, Inc. |
| K203547 | Nalu Neurostimulation System | Mar 25, 2021 | Substantially Equivalent | Nalu Medical, Inc. |
| K202274 | Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits | Nov 09, 2020 | Substantially Equivalent | Nalu Medical, Inc. |
| K201618 | Nalu Neurostimulation SCS system | Jul 15, 2020 | Substantially Equivalent | Nalu Medical, Inc |
| K191466 | SandShark Injectable Anchor (SIA) System | Nov 07, 2019 | Substantially Equivalent | Stimwave Technologies Inc. |
| K190960 | Nalu Lead Blank (50cm) | Jul 11, 2019 | Substantially Equivalent | Nalu Medical, Inc. |
| K182720 | Freedom Spinal Cord Stimulator (SCS) System | Mar 29, 2019 | Substantially Equivalent | Stimwave Technologies Incorporated |
| K183047 | Nalu Neurostimulation System | Mar 22, 2019 | Substantially Equivalent | Nalu Medical, Inc |
| K180981 | Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit | Sep 19, 2018 | Substantially Equivalent | Stimwave Technologies Incorporated |
| K172644 | Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base | Nov 03, 2017 | Substantially Equivalent | Stimwave Technologies Incorporated |
| K170141 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit | May 02, 2017 | Substantially Equivalent | Stimwave Technologies Incorporated |
| K162161 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit | Dec 16, 2016 | Substantially Equivalent | Stimwave Technologies Incorporated |
| K160600 | Freedom Spinal Cord Stimulator System | Aug 26, 2016 | Substantially Equivalent | STIMWAVE TECHNOLOGIES INCORPORATED |
| K150924 | A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device | Jul 27, 2015 | Substantially Equivalent | ANCHOR INNOVATION MEDICAL (A.I.M.) |
| K150517 | Freedom Spinal Cord Stimulator System | Jun 05, 2015 | Substantially Equivalent | STIMWAVE TECHNOLOGIES INCORPORATED |
| K141399 | FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM | Oct 10, 2014 | Substantially Equivalent | STIMWAVE TECHNOLOGIES INCORPORATED |
| K140272 | SWIFT-LOCK ANCHOR | May 02, 2014 | Substantially Equivalent | ST. JUDE MEDICAL |
| K130545 | MULTI LEAD TRIAL CABLE | Jun 18, 2013 | Substantially Equivalent | ST. JUDE MEDICAL |
| K123299 | MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS | Jan 18, 2013 | Substantially Equivalent | ST. JUDE MEDICAL NEUROMODULATION |
| K113611 | RAPID PROGRAMMER | Apr 20, 2012 | Substantially Equivalent | ST. JUDE MEDICAL |
| K113805 | FIXATE TISSUE BAND | Feb 23, 2012 | Substantially Equivalent | ANULEX TECHNOLOGIES, INC |
| K113400 | FIXATE TISSUE BAND | Dec 16, 2011 | Substantially Equivalent | ANULEX TECHNOLOGIES, INC |
| K112214 | OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS | Nov 17, 2011 | Substantially Equivalent | ST. JUDE MEDICAL NEUROMODULATION |
| K112849 | FIXATE TISSUE BAND | Oct 27, 2011 | Substantially Equivalent | ANULEX TECHNOLOGIES, INC |
| K111462 | FIXATE TISSUE BAND | Sep 08, 2011 | Substantially Equivalent | ANULEX TECHNOLOGIES, INC |
| K102523 | MULTI-LEAD TRIALING CABLE MODEL 355531 | Oct 26, 2010 | Substantially Equivalent | MEDTRONIC INC. |
| K092371 | SWIFT-LOCK ANCHOR, MODEL 1192 | Dec 23, 2009 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K091993 | RAPID PROGRAMMER, VERSION 3.3.0 | Jul 31, 2009 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS, INC. (ANS INC.) |
| K090907 | PENTA LEAD KITS, MODELS: 3227-3234 | Jun 02, 2009 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K081208 | CINCH ANCHOR, MODEL 1194 | Jul 18, 2008 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K072462 | WIDE SPACED QUATTRODE LEADS | Oct 11, 2007 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K070847 | TRIAL CABLE, 3009 | Apr 11, 2007 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K063080 | TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS | Dec 12, 2006 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K062041 | MODEL 3875 1 X 8 SC TEST STIMULATION LEAD | Aug 16, 2006 | Substantially Equivalent | MEDTRONIC INC. |
| K053250 | ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT | Dec 15, 2005 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K052374 | RAPID PROGEAMMER 3.0 | Nov 22, 2005 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K052418 | AXXESS BUTTERFLY ANCHOR | Sep 26, 2005 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K051773 | MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS | Jul 28, 2005 | Substantially Equivalent | MEDTRONIC INC.,NEUROLOGICAL DIVISION |
| K050922 | ANS SCS ACCESSORY KIT | May 18, 2005 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K050633 | TRIAL CABLE RETENTION CLIP | Apr 21, 2005 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K040609 | RAPID PROGRAMMER | Mar 25, 2004 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K040568 | POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS | Mar 25, 2004 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K033757 | MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM | Jan 30, 2004 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K033429 | LAMITRODE SPINAL CORD STIMULATION LEADS | Dec 04, 2003 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K033016 | PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892 | Oct 30, 2003 | Substantially Equivalent | MEDTRONIC NEUROLOGICAL |
| K032751 | MODIFICATION TO RENEW LEAD EXTENSION | Oct 06, 2003 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K032349 | PLACER | Oct 03, 2003 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K032034 | ANS AXXESS PERCUTANEOUS LEAD | Oct 03, 2003 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K032561 | RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR | Sep 11, 2003 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K030461 | A127 LEAD EXTENSION | Apr 24, 2003 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K030674 | MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD | Mar 28, 2003 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K030118 | RAPID PROGRAMMAR | Mar 11, 2003 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K022222 | LAMITRODE S-SERIES (S4 AND S8) LEADS | Aug 08, 2002 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEM,INC |
| K021518 | PAINDOC | Jun 06, 2002 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K013120 | PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 | Jan 24, 2002 | Substantially Equivalent | MEDAMICUS, INC. |
| K013063 | GRIP LOCK ANCHOR, MODEL 411374 | Dec 11, 2001 | Substantially Equivalent | MEDTRONIC NEUROLOGICAL |
| K010300 | MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION | Aug 01, 2001 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K010008 | AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX | Jul 16, 2001 | Substantially Equivalent | MICRONET MEDICAL, INC. |
| K011584 | MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF | Jun 22, 2001 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K000445 | MEDTRONIC MODEL 7499 EXTENSION | Apr 28, 2000 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K994097 | MEDAMICUS EPIDURAL INTRODUCER | Mar 01, 2000 | Substantially Equivalent | MEDAMICUS, INC. |
| K992946 | RENEW RECEIVER | Sep 24, 1999 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K991784 | RENEW LEAD EXTENSION | Jun 24, 1999 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K990469 | LAMITRODE LEADS | Jun 03, 1999 | Substantially Equivalent | ADVANCED NEUROMODULATION SYSTEMS |
| K990104 | MEDTRONIC MODEL 7495 EXTENSION KIT | Feb 09, 1999 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K972906 | MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA) | Feb 06, 1998 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K971756 | MEDTRONIC MODEL 3998 LEAD | Feb 03, 1998 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K972043 | MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER | Aug 22, 1997 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K964172 | MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL | Jul 03, 1997 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K953742 | BIFURCATED Y-EXTENSION | Nov 19, 1996 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K960728 | ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE) | May 22, 1996 | Substantially Equivalent | NEUROMED, INC. |
| K955291 | DUALSCREEN | May 17, 1996 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K954886 | MODEL NOS. 7495 AND 501826 EXTENSIONS | Nov 27, 1995 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K941342 | PAIN DOC | Oct 13, 1995 | Substantially Equivalent | REGULATORY & MARKETING SERVICES, INC. |
| K952459 | MEDTRONIC MODEL 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C LEADS OR, TRANSVERSE TRIPOLAR LEADS OR, TTL | Aug 30, 1995 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K943537 | MODEL 3470 X-TREL RF RECEIVER | Apr 12, 1995 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K934065 | MEDTRONIC MATTRIX 3271/3272 NEUROSTIMULATION SYSTEM | Feb 14, 1995 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K950127 | ALTERNATE 100% ETO STERILIZATION PROCESS AND ALTERNATE STERILIZATION FACCILITY | Jan 30, 1995 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K945103 | TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS) | Jan 11, 1995 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K930536 | NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC | Dec 15, 1994 | Substantially Equivalent | NEUROMED, INC. |
| K930498 | NEUROMED OCTRODE MODEL MNT-98 NEUROSTIMULATOR TRAN | Dec 12, 1994 | Substantially Equivalent | NEUROMED, INC. |
| K940416 | NEUROLOGICAL LEADS (PACKAGING MODIFICATION) | Jul 18, 1994 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K936099 | NEUROLOGICAL LEAD ACCESSORIES | Jul 11, 1994 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K934938 | TEMPORARY SCREENING LEAD/CATHETER KIT | Jun 14, 1994 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K932202 | MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT | May 04, 1994 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K932948 | MEDTRONIC MODEL 3625 SCREENER SYSTEM | Feb 03, 1994 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K930242 | INTRODE INT-8 | Feb 02, 1994 | Substantially Equivalent | NEUROMED, INC. |
| K921319 | NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30 | May 05, 1993 | Substantially Equivalent | NEUROMED, INC. |
| K924522 | MEDTRONIC MODEL 3080 PISCES-QUAD LEAD | Mar 18, 1993 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K923931 | MEDTRONIC MODEL 3487A PISCES-QUAD LEAD | Mar 18, 1993 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K923567 | MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD | Nov 05, 1992 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K921558 | MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS | Jul 07, 1992 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K913993 | MEDTRONIC MODELS 3982 A,B,C&D STAG ARRAY RES LEADS | Feb 07, 1992 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K913934 | MEDTRONIC MODEL 3586 RESUME LEAD | Jan 22, 1992 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K914433 | MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS | Dec 23, 1991 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K913442 | MEDTRONIC 3625 SCREENER SYSTEM | Nov 22, 1991 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K912764 | MEDTRONIC MODEL 3861 TEMPORARY SCREENING LEAD KIT | Nov 22, 1991 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K905569 | ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A | Jun 27, 1991 | Substantially Equivalent | BIOMEDICAL LIFE SYSTEMS, INC. |
| K905596 | NEUROMED OCTRODE MODEL MNR-88B/88C NEUROSTIM SYST | Mar 11, 1991 | Substantially Equivalent | NEUROMED, INC. |
| K905402 | ANTIGENZ CHLAMYDIA | Mar 11, 1991 | Substantially Equivalent | NORTHUMBRIA BIOLOGICALS LTD. |
| K903690 | MEDTRONIC (R) MODEL 3625 SCREENER | Feb 14, 1991 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K910199 | MEDTRONIC MODEL 3487A PISCES-QUAD LEAD | Feb 11, 1991 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K905407 | MODEL 3487A PISCES-QUAD,3587A RESUME,3586 RESUME | Feb 01, 1991 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K905255 | NEUROMED MODEL 1992 LS LAMITRODE LEAD | Jan 25, 1991 | Substantially Equivalent | NEUROMED, INC. |
| K903814 | NEUROMED TS8 TEST STIMULATOR | Jan 16, 1991 | Substantially Equivalent | NEUROMED, INC. |
| K901499 | NEUROMED OCTRODE MODEL MNR-88 W/98 ADAPTER NEURO. | Jun 29, 1990 | Substantially Equivalent | NEUROMED, INC. |
| K890061 | MODEL 3586 RESUME LEAD | Apr 30, 1990 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K892884 | MEDTRONIC MODEL 3530 PERCUTANEOUS EXTENSION | Aug 07, 1989 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K885033 | MODEL 3487A PISCES EPIDURAL LEAD | Jan 17, 1989 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K884948 | MODEL 3587A RESUME EPIDURAL LEAD | Jan 17, 1989 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K883780 | XTREL, MODEL NUMBER 3425 | Nov 30, 1988 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K881491 | MODEL 3487A PISCES EPIDURAL LEAD | May 25, 1988 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K873675 | MODIFIED #3587 RESUME SE-4/#3487 PISCES-QUAD | Oct 06, 1987 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K862915 | MULTISTIM(4-CHANNEL), MULTISTIM-OCTRODE(8 CHANNEL) | Oct 06, 1986 | Substantially Equivalent | NEUROMED, INC. |
| K855107 | MEDTRONIC MODEL 3422A TRANSMITTER ANTENNA KIT | May 09, 1986 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K860185 | UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER | Apr 04, 1986 | Substantially Equivalent | NEUROMED, INC. |
| K860158 | 8-CHANNEL MULTIPROG IMPLANT SPINAL CORD STIMULATOR | Mar 07, 1986 | Substantially Equivalent | NEUROMED, INC. |
| K853643 | MULTISTIM LAMINECTOMY ELECTRODE | Nov 14, 1985 | Substantially Equivalent | NEUROMED, INC. |
| K852326 | UNISTIM UNT-1 | Nov 14, 1985 | Substantially Equivalent | NEUROMED, INC. |
| K852920 | QUADRA CATH ELECT(3MM SIZES) 1990J, JF, JP + JPF | Oct 10, 1985 | Substantially Equivalent | NEUROMED, INC. |
| K852827 | CORDIS EXTERNAL NEURAL STIMULATOR MODEL 911A | Aug 14, 1985 | Substantially Equivalent | CORDIS CORP. |
| K844115 | MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL | Feb 06, 1985 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K841584 | MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL | May 14, 1984 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K833990 | SPINAL CORD STIMULATION SYS SE-4 | Mar 19, 1984 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K833809 | NEURAL STIMULATOR MONITOR | Dec 01, 1983 | Substantially Equivalent | INSTROMEDIX, INC. |
| K831746 | PISCES #3487 EPIDURAL LEAD FOR SPINAL | Aug 11, 1983 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K823530 | STIMUCORD EXTERNAL NEURAL STIM. 911A | Dec 15, 1982 | Substantially Equivalent | CORDIS CORP. |
| K820988 | MEDTRONIC #1992-2 DUAL RATE TRANSMITTER | Jun 23, 1982 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K812155 | MEDTRONIC DUAL CHANNEL SPINAL CORD STIM | Oct 08, 1981 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K812154 | MEDTRONIC #3484 PISCES EPIDURAL LEAD | Aug 20, 1981 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K811655 | MYELOSTAT DORSAL CORD STIMULATOR | Jul 01, 1981 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K810182 | PROGRAMMABLE SPINAL CORAL STIM. SYSTEM | Apr 03, 1981 | Substantially Equivalent | ELECTRONIC DIAGNOSTICS, INC. |
| K810319 | CORDIS STIMUCORD EXTERNAL NEUTRAL STIM | Feb 19, 1981 | Substantially Equivalent | CORDIS CORP. |
| K801384 | MYELOSTAT DORSAL CORD STIMULATOR, ETC. | Jul 08, 1980 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K800193 | MEDTRONIC PISCES GENERATION II LEAD KIT | Feb 05, 1980 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K790790 | PISCES-SELECTOR X | May 25, 1979 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K780758 | NEUROLOGICAL SCREENING STIMULATOR M 3623 | May 19, 1978 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K780001 | EPIDURAL LEAD - MODEL 3481 | Jan 17, 1978 | Substantially Equivalent | MEDTRONIC VASCULAR |
FEI Numbers
This FDA classification entry is associated with 33 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 33 registration numbers. Click on an entry to view related FDA registrations.