FDA Registration
Active
🇺🇸 United States
Abbott Medical
Reg #: 3006705815
·
FEI: 3006705815
·
Expires 2026
Products
21
Proprietary Names
206
Establishment Types
2
Classifications
21
Registration Details
- Registration Name
- Abbott Medical
- Registration Number
- 3006705815
- FEI Number
- 3006705815
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- LOT A INTERIOR - No. 2 RD KM 67.5, SANTANA INDUSTRIAL PARK
- City
- Arecibo
- State
- PR
- ZIP
- 00612
- Country
- US
Regulatory Submissions
- 510(k) Number
- K960728
- PMA Number
- P140033
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | NVN | Class 3 | Unknown | No | 2017-01-31 |
| Implantable Pulse Generator, Pacemaker (Non-Crt) | LWP | Class 3 | Unknown | No | 2017-01-31 |
| Implantable Pacemaker Pulse-Generator | DXY | Class 3 | Cardiovascular | No | 2017-01-31 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2007-11-09 |
| Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | NIK | Class 3 | Unknown | No | 2007-11-09 |
| Pacemaker/Icd/Crt Non-Implanted Components | OSR | Class 3 | Unknown | No | 2007-11-09 |
| Pulse Generator, Permanent, Implantable | NVZ | Class 3 | Unknown | No | 2007-11-09 |
| Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode | OJX | Class 3 | Unknown | No | 2007-11-09 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | NKE | Class 3 | Unknown | No | 2007-11-09 |
| Permanent Pacemaker Electrode | DTB | Class 3 | Cardiovascular | No | 2006-05-22 |
| Permanent Defibrillator Electrodes | NVY | Class 3 | Unknown | No | 2006-05-22 |
| Programmer, Pacemaker | KRG | Class 3 | Cardiovascular | No | 2007-11-09 |
| Pulse-Generator, Single Chamber, Sensor Driven, Implantable | LWO | Class 3 | Unknown | No | 2007-11-02 |
| Leadless Pacemaker | PNJ | Class 3 | Cardiovascular | No | 2022-04-06 |
| Stimulator, Spinal-Cord, Implanted (Pain Relief) | GZB | Class 2 | Neurology | No | 2008-05-19 |
| Heart-Valve, Mechanical | LWQ | Class 3 | Unknown | No | 2007-10-16 |
| Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy | QRB | Class 3 | Unknown | No | 2016-09-21 |
| Stimulator, Electrical, Implanted, For Parkinsonian Tremor | MHY | Class 3 | Unknown | No | 2016-09-21 |
| Stimulator, Electrical, Implanted, For Essential Tremor | PJS | Class 3 | Unknown | No | 2016-09-21 |
| Stimulator, Electrical, Implanted, For Parkinsonian Symptoms | NHL | Class 3 | Unknown | No | 2016-09-21 |
| Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | LGW | Class 3 | Unknown | No | 2007-11-30 |
Proprietary Names
Zenex MRI PM1283
St Jude Medical MR Conditional Pacemaker System
Zenex MRI PM2283
Quadra Assura CRT-D, Unify Assura CRT-D
Promote CRT-Ds, Stylet Kit,
Merlin Patient Care System Accessories, Slit Suture Sleeve, Stylet Guide, Vein Pick
Current DR, VR ICDs, Promote ICDs, Merlin Antenna
QuickFlex Micro Lead, Promote Accel CRT-Ds, Fortify VD DR ICDs, Unify CRT-Ds, Merlin Antenna Adapter
Promote Q CRT-Ds, Promote Quadra CRT-Ds, Quartet Lead, Unify Quadra CRT-D, Wireless Broadband Kit
Flushing Tool, Merlin@home Transmitter Software, Durata Active Fixation Leads
Merlin Cable Adapter, Merlin "M" Adapter, Merlin Patient System Analyzer, Slit Suture Sleeve,
Merlin Patient Care System Software Model 3330 Version 18.1.1
CRT Leads, Quickflex Left Heart Leads
Entrant Models - CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T
Gallant Models - CDHFA500B, CDHFA500D, CDHFA500Q, CDHFA500T
Avant Models CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T
Neutrino NxT Models - CDHFA600B, CDHFA600D, CDHFA800B, CDHFA800D, CDHFA800Q
Neutrino NxT Models - CDHFA600Q, CDHFA800T, CDHFA600T
Lead Cap IS-1/DF-1/SJ4, Merlin Patient Care System Software, Programmer Software, Wireless USB Adapter
IS4/DF4 Connector Sleeve, IS4/DF4 Plug Accessory Kit, Ellipse DR ICD, Ellipse VR ICD. Fortify Assura ICD
Merlin@home Transmitter, 3-Lead ECG Cable, Current+ DR VR, ICDs, Promote+ ICDs, Current DR VR ICDs, Promote+ CRT-Ds
Guidewire, Stylet, Tip Introducer/Torque Tool, Merlin Patient Care System
Passive Plus and Isoflex Lead Families, Passive Plus DX Endocardial Steroid Eluting, Passive Fixation Pacing Leads
Suture Sleeve Accessory DS2A088
Tendril SDX, Tendril ST, Tendril STS, OptiSense, Tendril DX Leads
UltiPace Bradycardia Pacing Lead Model LPA1231
Regency family of pacemakers
Quadra Allure MP
Frontier, Frontier II, Anthem Family of CRT-PS
Current DR, VR ICD, Merlin Antenna, Promote ICD
Vein Pick
Neutrino NxT Models - CDVRA800Q, CDVRA600Q, CDDRA800Q, CDDRA600Q, CDVRA800T, CDVRA600T, CDDRA800T, CDDRA600T
Fortify VR, DR ICD, Wireless Broadband Kit, IS4/DF4 Port Plug Accessory Kit, Ellipse DR, Ellipse VR
Merlin Patient Care System Software
Promote+ ICD, Promote CRT-D, Promote+ CRT-D, Merlin.net Patient Care Network s/w
Silicone Oil
DF-1 Receptacle Plug, Hex Wrench,
Entrant Models - CDDRA300Q, CDVRA300T, CDDRA300T
Merlin Live Connect Software Model MLC1000
Avant Models - CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T
Gallant Models - CDVRA500Q, CDDRA500Q, CDVRA500T, CDDRA500T
Integrity ADx XL DR, DR, SR, Verity ADx XL DR, XL DC, XL SR, XL, SC, XL VDR
Stylet Kit, Promote ICD
Programmer Sotware,Merlin@home Tansmitter, Wireless USB Adapter, Current+ DR, VR ICD, Current DR, VR ICD
IS-1 Receptacle Plus, Medical Adhesive
Merlin@home Transmitter software, Durata Active Fixation Leads, Lead Cap (IS1/DF1/SJ4
Aveir Link Module - Model LSL02
Aveir Delivery Catheter - Models LSCD201, LSCD111
Aveir Leadless Pacemaker - Models LSP112V, LSP201A, LSP202V
Aveir Patient Transmitter Software - Model LSRM1000
Aveir Patient Transmitter - Model LSRM01
Aveir Patient Transmitter Wired Electrodes - Model LSRMC01
AVEIR AR 2 Leadless Pacemaker - Model LSP203A
Zephyr XL SR; Accent SR, SR RF, DR, DR RF; Anthem CRT-P, RF CRT-P; Sustain XL, DC/SC; Sustain DR/SR
Medical Adhesive, Integrity Micro SR DR, ECG Adapter Cable,
Pacing System Analyzer Wand, Victory XL DR, DR, SR; Victory AF DR; Zephyr XL DR, DR, SR;
Allure RF, Allure Quadra RF, Allure, Allure Quadra, Endurity, Assurity+, and Assurity Family of Pacemakers
Accent; Sustain XL SC, DC, SR, DR;
Identity ADX, Identity, DC, VDR, Integrity ADx XL, Integrity DR, SR, Verity ADx XL, DR, XL , DC, VDR
Octrode
Quattrode
Masters Series HP Valved Graft with Gelweave Valsalva Technology (VAVGJ)
Masters Series Mechanical Heart Valve with Expanded Polyester Sewing Cuff (Aortic)
Masters Series Aortic Valved Graft with Hemashield Graft Technology (CAVGJ)
Masters Series Mechanical Heart Valve with Expanded Polyester Sewing Cuff (Mitral)
Masters Series Mechanical Heart Valve (Aortic)
Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (Mitral)
SJM Masters Series Mechanical Heart Valve
Masters Series Mechanical Heart Valve (Mitral)
Masters Series Mechanical Heart Valve with Expanded Hemodynamic Plus (HP) Sewing Cuff (Aortic)
SJM Masters Series Mechanical Heart Valve Mitral Expanded Hemodynamic Plus (HP)
Regent Mechanical Heart Valve
Masters Series Mechanical Heart Valve with PTFE Sewing Cuff (Aortic)
Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (Aortic)
Masters Series Mechanical Heart Valve with PTFE Sewing Cuff (Mitral)
Regent Mechanical Heart Valve (FlexCuff)
SJM Masters Series Mechanical Heart Valve Aortic Expanded PTFE Cuff
Patient Magnet
Charging Apparel, lumbar (model 16750)
Charger Kit - Pectoral (model 66000)
4 Channel DBS Extension
St. Jude Medical Infinity DBS System
Charger (model 16000)
St. Jude Medical Infinity DBS System 8CH Directional Lead
Infinity 5 IPG, MDT Header
4 Channel DBS Lead
Brio Patient Programmer
Infinity 7 IPG, MDT Header
NeuroSphere Clinician Programmer (model 55600)
Infinity 7 IPG
DBS Charging System (model 66700)
Liberta RC DBS IPG (model 62400)
St. Jude Medical Infinity DBS System 8CH Flex Extn
Port Plug (model 12710)
St. Jude Medical Infinity DBS System 4CH Extn
Infinity 5 IPG
Multi Lead Trial Cable (MLTC)
NeuroSphere Patient Controller (model 55500)
Brio LE Charging System
8-Channel Adapter
Brio Implantable Pulse Generator
Brio LE Charger Accessory
St. Jude Medical Deep Brain Stimulator External Pulse Generator
St. Jude Medical Infinity DBS System 4CH Lead
St. Jude Medical Patient Controller App
St. Jude Medical Clinician Programmer App
Charging Apparel, pectoral (model 16760)
St. Jude Medical Infinity DBS System 4CH Flex Extn
NeuroSphere Digital Health App (3876)
Optisure High Voltage Lead Family
Durata, Durata DF4 Transvenous Defibrillation Leads
Patient Magnet (Model 1210)
BurstDR stimulation temp evaluation patient programmer (Model 3857)
Tripole 16 Lamitrode (Model 3219)
Power Cord, Portable Charger (Model 3714)
Proclaim 7 IPG (Medtronic header) (Model 3663)
Stylet, Bent, 90cm (Model 1126)
Eon Charging System (Model 3726)
Quattrode Percutaneous Lead Kit, 30cm, 3/4 Spacing (Model 3143)
Octrode Percutaneous Lead Kit, 60cm (Model 3186)
Prodigy MRI patient programmer (Model 3856)
Lamitrode Percuatenous , 8 electrode, 90cm (Model 3268)
Charger (Model 3721)
Strain Relief (Model 1109)
Rapid Programmer (Model 3834)
IRDA communication cable (Model 1280)
Octrode Percutaneous Lead Kit, 30cm (Model 3183)
Quattrode Percutaneous Lead Kit, 60cm, 3/4 Spacing (Model 3146)
Battery pack (Model 1254)
A127 Lead Extension
SCS EPG 2-Port Header (Model 3032)
Cinch Lead Anchor (Model 1194)
Genesis Programmer (Model 3850)
Stylet, Straight, 60cm (Model 1123)
TriCentrus, 16 Lead 60cm Length (Model 3292)
Torque Wrench (Model 1101)
Charger Antenna 36" (Model 3732)
Prodigy patient programmer (Model 3855)
Power adapter, rapid programmer (Model 1622)
Eon Mini Charging System (Model 3722)
8-Channel Adapter, B, 10cm (Model 2321)
Stylet, Bent, 30cm (Model 1122)
Introde-AK Lead Introducer (Model 1103)
Proclaim 7 IPG (Model 3667)
Proclaim Plus 7 (Medtronic header) (Model 3673)
Swift-Lock Anchor (Model 1192)
Patient Programmer (Model 3852)
Proclaim 5 Elite IPG (Model 3660)
Prodigy Charger (Model 3730)
Proclaim 5 IPG (Model 3665)
Proclaim Plus 5 (Medtronic header) (Model 3671)
Eon LE Mobile Charger (Model 3726)
Quattrode Percutaneous Lead Kit, 60cm, 3/6 Spacing (Model 3156)
EonC (Model 3688)
Lamitrode 4 Surgical Lead Kit, 60cm (Model 3240)
Quattrode Percutaneous Lead Kit, 30cm, 3/6 Spacing (Model 3153)
External Pulse Generator (EPG) (Model 3599)
C-Series Lamitrode Leads (Models 3245)
St. Jude Medical Clinician Programmer (Model 3874)
Eon Mini (Model 3788)
Pouch, Portable Charger (Model 7241)
Eon Patient Programmer (Model 3851)
Lamitrode 44 Surgical Lead Kit, 60cm (Model 3244)
SCS Accessory Kit Sterile (Model 1701)
Dual Extension (Models 3341, 3343, 3346)
S-Series Lamitrode Leads (Models 3243, 3283, 3246, 3286)
Stylet, Bent, 60cm (Model 1124)
Proclaim 7 Elite IPG (Model 3662)
Patient Wand (Model 1232)
St. Jude Medical Patient Controller (Model 3875)
Quattrode® Trial Lead Wide Spaced (Model 3066)
Stylet, Straight, 30cm (Model 1121)
Octrode Lead, 8 electrode, 3/4mm, 90cm (Model 3189)
Penta Lead (Model 3228)
Port Plug Accessory kit (Model 1108)
Lead Anchor, Long (Model 1106)
SCS Charging System (model 36700)
Port Plug Accessory Kit (Model 1111)
Proclaim Plus 7 (Model 3672)
Quattrode Lead, 4 electrode, 3/4mm, 90cm (Model 3149)
Lead Anchor, Butterfly (Model 1105)
EPG Non-Adhesive Pouch (Model 1214)
Protege MRI IPG (Model 3771)
Lamitrode® 88 Lead Kit, 60cm Length (Model 3288)
Stylet, Straight, 90cm(Model 1125)
Quattrode Lead, 4 electrode, 3/6mm, 90cm (Model 3159)
Charger Accessory (Eon Mini LE) (Model 3720)
8-Channel Adapter, B, 60cm (Model 2326)
Extension, 60cm (Model 3386)
Proclaim 5 IPG (Medtronic header) (Model 3661)
8-Channel Adapter (Model 2311, 2316)
MTS joining sleeve (Model 1627)
Lead Instertion Tool (Model 1803)
SCS EPG 2-Port Header (model 3042)
Proclaim Plus 5 (Model 3670)
Tripole 16C Lamitrode Lead (Model 3214)
Eon Charger, Antenna (Model 3728)
Charger Accessories Kit, lumbar (model 36000)
Protege MRI patient programmer (Model 3853)
Protege IPG (Model 3789)
Patient manual and magnet (Model 3884)
Power Supply, Portable Charger (Model 3713)
Guide Wire for Percutaneous Leads (Model 1102)
Eterna SCS IPG (model 32400)
Lead and Extensions Insertion Tool (Model 1803)
Extension, 30cm (Model 3383)
Establishment Types
Manufacture Medical Device
Sterilize Medical Device for Another Party (Contract Sterilizer)