The amplatzer™ amulet™ left atrial appendage occluder is a percutaneous transcatheter device intended to prevent thrombus embolization from the left atrial appendage (laa) in patients who have nonvalvular atrial fibrillation. The amplatzer™ amulet™ left atrial appendage occluder may be considered for use in patients who are at increased risk for stroke and systemic embolism based on chads2 or cha2ds2-vasc scores, 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.
| Device | Amplatzer™ Amulet™ Left Atrial Appendage Occluder |
| Generic Name | System, Appendage Closure, Left Atrial |
| Applicant | Abbott Medical |
| Date Received | 2020-12-31 |
| Decision Date | 2021-08-14 |
| PMA | P200049 |
| Supplement | S |
| Product Code | NGV |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Medical 5050 Nathan Lane North plymouth, MN 55442 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200049 | Original Filing | |
| S004 | 2022-06-16 | 30-day Notice |
| S003 | 2021-11-05 | 30-day Notice |
| S002 | ||
| S001 | 2021-08-24 | 30-day Notice |