FDA Registration
Active
🇺🇸 United States
Pulse-generator, single chamber
Reg #: 2017865
·
FEI: 2017865
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
2
Classifications
5
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
- P970013
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 |
|---|---|---|---|---|---|
| Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | NIK | Class 3 | Unknown | No | 2007-11-09 |
| Pulse-Generator, Single Chamber, Sensor Driven, Implantable | LWO | Class 3 | Unknown | No | 2007-11-09 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2007-11-09 |
| Implantable Pulse Generator, Pacemaker (Non-Crt) | LWP | Class 3 | Unknown | No | 2007-11-09 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | NKE | Class 3 | Unknown | No | 2007-11-09 |
Proprietary Names
Pulse-generator, single chamber
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198