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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 Rd. B E.
St. Paul, MN 55117
PMA NumberP200049
Supplement NumberS012
Date Received06/20/2025
Decision Date09/18/2025
Product Code NGV 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modifications to the Amplatzer™ Amulet™ Left Atrial Appendage Occluder Instructions for Use (IFU) and Patient Manual to remove a warning related to late pericardial effusions and to update your post implant medication regimen to include the use of oral anticoagulants.
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