FDA device listing
Amplatzer Amulet Left Atrial Appendage Occluder,Amplatzer Cardiac Plug
FDA device listing 1527443772 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Amplatzer Amulet Left Atrial Appendage Occluder,Amplatzer Cardiac Plug |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Product codes | MLV |
| Device names | MLV - Transcatheter Septal Occluder |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.MLV |
| Review panels | Cardiovascular |
| Registered establishments | Abbott Medical, Abbott Medical Costa Rica Limitada (Structural Heart) |
| Establishment registrations | 2135147, 3014918977 |
| FEI numbers | 3005334138, 3014918977 |
| Establishment operations | Manufacturer, 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