FDA device listing
Ampere Generator,Ampere Generator Generator Accessories,Ampere Generator Kit,Ampere Remote Control,Contact Therapy Cool…
FDA device listing 1734136513 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Ampere Generator,Ampere Generator Generator Accessories,Ampere Generator Kit,Ampere Remote Control,Contact Therapy Cool Path Duo Ablation Catheter,Cool Path Duo Ablation Catheter, MediGuide Enabled,Cool Point™ Irrigation Pump,Safire Duo Ablation Catheter, MediGuide Enabled,Safire™ TX Ablation Catheter,Therapy™ Ablation Catheter,Therapy Cool Flex Ablation Catheter,Therapy Cool Path Ablation… |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Product codes | OAD |
| Device names | OAD - Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.OAD |
| Review panels | Cardiovascular |
| Registered establishments | IRVINE BIOMEDICAL. INC., St. Jude Medical, St. Jude Medical, Atrial Fibrillation Division, Inc. |
| Establishment registrations | 2030404, 2184149, 3012179728 |
| FEI numbers | 1000139754, 1000519796, 3012179728 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database