FDA Registration
Active
🇲🇾 Malaysia
Merlin Patient Care System Software Model 3330 Version 18.1.1
Reg #: 3008494315
·
FEI: 3008377825
·
Expires 2025
Products
5
Proprietary Names
3
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Abbott Medical
- Registration Number
- 3008494315
- FEI Number
- 3008377825
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Plot 102, Lebuhraya Kampung Jawa, Bayan Lepas Industrial Zone
- City
- Penang Pulau Pinang
- Country
- MY
Regulatory Submissions
- PMA Number
- P030035
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
US Agent
- Business Name
- Abbott Medical
- Contact Name
- Kathy Berg
- Address
- 8300 East Pacesetter Way
- City
- Scottsdale
- State
- AZ
- ZIP
- 85255
- Country
- US
- [email protected]
- Phone
- 480 5026330
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 | 2007-11-02 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2007-11-02 |
| Implantable Pulse Generator, Pacemaker (Non-Crt) | LWP | Class 3 | Unknown | No | 2007-11-02 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | NKE | Class 3 | Unknown | No | 2007-11-02 |
| Pulse-Generator, Single Chamber, Sensor Driven, Implantable | LWO | Class 3 | Unknown | No | 2007-11-02 |
Proprietary Names
Merlin Patient Care System Software Model 3330 Version 18.1.1
Frontier, Frontier II, Anthem Family of CRT-PS
Quadra Allure MP
Establishment Types
Manufacture Medical Device