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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAmplatzer Amulet Left Atrial Appendage Occluder
Generic NameSystem, appendage closure, left atrial
ApplicantAbbott Medical
177 County Road B East
St. Paul, MN 55117
PMA NumberP200049
Supplement NumberS003
Date Received11/05/2021
Decision Date11/16/2021
Product Code NGV 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Update to the dome weld and end screw weld visual acceptance criteria.
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