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Device | Amplatzer™ Amulet™ Left Atrial Appendage Occluder |
Generic Name | System, appendage closure, left atrial |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P200049 |
Date Received | 12/31/2020 |
Decision Date | 08/14/2021 |
Product Code |
NGV |
Docket Number | 21M-0911 |
Notice Date | 08/21/2021 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02879448
|
Expedited Review Granted? | No |
Combination Product | No |
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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 |