FDA Registration
Active
🇺🇸 United States
Merlin Patient Care System Software Model 3330 Version 18.1.1
Reg #: 3006705815
·
FEI: 3006705815
·
Expires 2025
Products
7
Proprietary Names
2
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Abbott Medical
- Registration Number
- 3006705815
- FEI Number
- 3006705815
- Status
- Active
- Expiry Year
- 2025
- 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
- PMA Number
- P880006
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 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2007-11-09 |
| Programmer, Pacemaker | KRG | Class 3 | Cardiovascular | No | 2007-11-09 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | NKE | Class 3 | Unknown | No | 2007-11-09 |
| Implantable Pulse Generator, Pacemaker (Non-Crt) | LWP | Class 3 | Unknown | No | 2007-11-09 |
| Pulse Generator, Permanent, Implantable | NVZ | Class 3 | Unknown | No | 2007-11-09 |
| Implantable Pacemaker Pulse-Generator | DXY | Class 3 | Cardiovascular | No | 2007-11-09 |
Proprietary Names
Merlin Patient Care System Software Model 3330 Version 18.1.1
Regency family of pacemakers
Establishment Types
Manufacture Medical Device