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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceAmplatzer™ Amulet™ Left Atrial Appendage Occluder
Generic Namesystem, appendage closure, left atrial
Applicant
Abbott Medical
5050 nathan lane north
plymouth, MN 55442
PMA NumberP200049
Date Received12/31/2020
Decision Date08/14/2021
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S003 
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