FDA Registration
Active
🇺🇸 United States
Zephyr XL SR; Accent SR, SR RF, DR, DR RF; Anthem CRT-P, RF CRT-P; Sustain XL, DC/SC; Sustain DR/SR
Reg #: 2017865
·
FEI: 2017865
·
Expires 2025
Products
8
Proprietary Names
7
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- ABBOTT MEDICAL
- Registration Number
- 2017865
- FEI Number
- 2017865
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 15900 Valley View Court
- City
- Sylmar
- State
- CA
- ZIP
- 91342
- Country
- US
Regulatory Submissions
- PMA Number
- P880086
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 |
|---|---|---|---|---|---|
| Implantable Pulse Generator, Pacemaker (Non-Crt) | LWP | Class 3 | Unknown | No | 2006-08-15 |
| Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | NIK | Class 3 | Unknown | No | 2006-08-15 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2006-08-15 |
| Permanent Pacemaker Electrode | DTB | Class 3 | Cardiovascular | No | 2006-08-15 |
| Implantable Pacemaker Pulse-Generator | DXY | Class 3 | Cardiovascular | No | 2006-08-15 |
| Programmer, Pacemaker | KRG | Class 3 | Cardiovascular | No | 2006-08-15 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | NKE | Class 3 | Unknown | No | 2006-08-15 |
| Pulse Generator, Permanent, Implantable | NVZ | Class 3 | Unknown | No | 2006-08-15 |
Proprietary Names
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,
Accent; Sustain XL SC, DC, SR, DR;
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
Merlin Patient Care System Software Model 3330 Version 18.1.1
Identity ADX, Identity, DC, VDR, Integrity ADx XL, Integrity DR, SR, Verity ADx XL, DR, XL , DC, VDR
Establishment Types
Manufacture Medical Device