FDA device listing
Ampere™ Footswitch,Ampere Generator,Ampere™ Generator Accessories,Ampere™ Generator Fiber Cord Assembly Remote,Ampere™…
FDA device listing 1906099585 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Ampere™ Footswitch,Ampere Generator,Ampere™ Generator Accessories,Ampere™ Generator Fiber Cord Assembly Remote,Ampere™ Generator Kit,Ampere™ Remote Control,FlexAbility Ablation Catheter,FlexAbility Ablation Catheter, Sensor Enabled,IBI 1500T9-CP V1.6 Cardiac Ablation Generator,Safire BLU Duo Ablation Catheter,Sensor Enabled™ Ablation Connection Cable,Therapy Cool Flex Ablation Catheter,Therapy… |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | P110016 |
| 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 | Abbott Medical Costa Rica Ltda., IRVINE BIOMEDICAL. INC., St. Jude Medical, St. Jude Medical, Atrial Fibrillation Division, Inc., St. Jude Medical, Cardiology Division, Inc., St. Jude Medical Coordination Center BVBA European Distribution Center |
| Establishment registrations | 2030404, 2182269, 2184149, 3005334138, 3008452825, 3012179728, 3012552532 |
| FEI numbers | 2182269, 1000139754, 1000519796, 3005334138, 3008452825, 3012179728, 3012552532 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, Foreign Exporter, Repackager/Relabeler |
| 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