Amplatzer Amulet Left Atrial Appendage Occluder
FDA premarket approval P200049 · System, appendage closure, left atrial
PMA numberP200049
Approval
- Applicant
- Abbott Medical
- Received
- December 31, 2020
- Decision date
- August 14, 2021 (APPR)
- Supplements
- 19, latest August 28, 2026
- Product code
- NGV – System, Appendage Closure, Left Atrial
Approval order statement
Approval for The Amplatzer Amulet Left Atrial Appendage Occluder. The device is a percutaneous transcatheter device intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.