FDA Registration
Active
🇺🇸 United States
Safire Catheter Extension Cable
Reg #: 2182269
·
FEI: 2182269
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- St. Jude Medical, Atrial Fibrillation Division, Inc.
- Registration Number
- 2182269
- FEI Number
- 2182269
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 14901 DEVEAU PL.
- City
- Minnetonka
- State
- MN
- ZIP
- 55345
- Country
- US
Regulatory Submissions
- PMA Number
- P960016
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 | 2007-12-11 |
Proprietary Names
Safire Catheter Extension Cable
Ampere Generator
Safire Bi-Directional Catheter
Livewire TC Ablation Catheter
Ampere Remote Control
Ampere Generator Fiber Cord Assembly Remote
Ampere Generator Kit
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device