FDA Registration
Active
🇺🇸 United States
Therapy Cool Path Duo Ablation Catheter
Reg #: 3012179728
·
FEI: 3012179728
·
Expires 2025
Products
1
Proprietary Names
12
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- St. Jude Medical
- Registration Number
- 3012179728
- FEI Number
- 3012179728
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2305 Walnut Street
- City
- Roseville
- State
- MN
- ZIP
- 55113
- Country
- US
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 |
|---|---|---|---|---|---|
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2020-03-24 |
Proprietary Names
Therapy Cool Path Duo Ablation Catheter
Ampere Remote Control
Contact Therapy Cool Path Duo Ablation Catheter
Safire Duo Ablation Catheter, MediGuide Enabled
Ampere Generator Kit
Therapy Cool Flex Ablation Catheter
Cool Path Duo Ablation Catheter, MediGuide Enabled
Therapy Dual-8 Ablation Catheter
Therapy Cool Path Ablation Catheter
Ampere Generator
Ampere Generator Generator Accessories
Cool Point Irrigation Pump
Establishment Types
Manufacture Device in the United States for Export Only