Amplatzer™ Amulet™ Left Atrial Appendage Occluder

FDA premarket approval P200049 · decided 2021-08-14

Approval details

PMA number

P200049

Trade name

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

Days to decision

226 days

Decision code

APPR

Product code

NGV

Advisory committee

Cardiovascular

Expedited review

No

Location

St. Paul, MN

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 antico

510(k) clearances by this applicant