FDA device listing
Ampere™ Generator,Ampere™ Generator Kit,Ampere™ Generator Software Upgrade,Ampere™ Remote Control,TactiFlex™ Duo Sensor…
FDA device listing 1847145763 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Ampere™ Generator,Ampere™ Generator Kit,Ampere™ Generator Software Upgrade,Ampere™ Remote Control,TactiFlex™ Duo Sensor Enabled™ Ablation Catheter,TactiFlex™ Sensor Enabled™ Ablation Catheter,TactiSys™ Quartz Equipment,TactiSys™ Quartz Equipment Software Upgrade,TactiSys™ Quartz TactiFlex™ Radiofrequency Cable,Unified Connector RF SE Cable, Radiofrequency Cable |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | P220013 |
| Product codes | OAE |
| Device names | OAE - Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.OAE |
| Review panels | Cardiovascular |
| Registered establishments | Abbott Medical Costa Rica Ltda., St. Jude Medical, St. Jude Medical, Atrial Fibrillation Division, Inc., St. Jude Medical, Cardiology Division, Inc. |
| Establishment registrations | 2184149, 3005334138, 3008452825, 3012179728 |
| FEI numbers | 1000139754, 3005334138, 3008452825, 3012179728 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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