FDA device listing
Amplatzer™ Amulet™ Left Atrial Appendage Occluder
FDA device listing 1772560416 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Amplatzer™ Amulet™ Left Atrial Appendage Occluder |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | P200049 |
| Product codes | NGV |
| Device names | NGV - System, Appendage Closure, Left Atrial |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.NGV |
| Review panels | Cardiovascular |
| Registered establishments | Abbott Medical, Abbott Medical Costa Rica Limitada (Structural Heart), St. Jude Medical |
| Establishment registrations | 2135147, 3007113487, 3012179728, 3014918977 |
| FEI numbers | 3005334138, 3007113487, 3012179728, 3014918977 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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