FDA Registration
Active
🇺🇸 United States
Ampere Generator Kit
Reg #: 2184149
·
FEI: 1000139754
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- St. Jude Medical, Atrial Fibrillation Division, Inc.
- Registration Number
- 2184149
- FEI Number
- 1000139754
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- One St. Jude Medical Drive
- City
- Saint Paul
- State
- MN
- ZIP
- 55117
- Country
- US
Regulatory Submissions
- PMA Number
- P040014
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 |
|---|---|---|---|---|---|
| Cardiac Ablation Percutaneous Catheter | LPB | Class 3 | Unknown | No | 2008-02-13 |
Proprietary Names
Ampere Generator Kit
Ampere Generator
Ampere RF Ablation Generator
Therapy Ablation Catheter
Grounding Cable 1710
Ampere Remote Control
Ampere Generator Fiber Cord Assembly Remote
Electrophysiology Cable
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device