FDA device listing
Ampere Generator,Ampere™ Generator Fiber Cord Assembly Remote,Ampere™ Generator Kit,Ampere™ Remote Control,Cool Point…
FDA device listing 1235664855 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Ampere Generator,Ampere™ Generator Fiber Cord Assembly Remote,Ampere™ Generator Kit,Ampere™ Remote Control,Cool Point Irrigation Pump,Cool Point™ Irrigation Pump Pressure Alarm Adapter Cable,Cool Point Tubing Set,Electrophysiology Cable 1779 |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | P060019 |
| Product codes | LPB, OAD |
| Device names | LPB - Cardiac Ablation Percutaneous Catheter, OAD - Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.LPB, ORCA1.OAD |
| Review panels | Cardiovascular |
| Registered establishments | IRVINE BIOMEDICAL. INC., St. Jude Medical, St. Jude Medical, Atrial Fibrillation Division, Inc., St. Jude Medical, Cardiology Division, Inc. |
| Establishment registrations | 2030404, 2184149, 3005334138, 3012179728 |
| FEI numbers | 1000139754, 1000519796, 3005334138, 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