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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.
 
DeviceWATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Left Atrial Appendage Closure D
Generic NameSystem, appendage closure, left atrial
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP130013
Supplement NumberS081
Date Received10/10/2025
Decision Date11/06/2025
Product Code NGV 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
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 additional warnings and instructions in to the WATCHMAN FLX and WATCHMAN FLX Pro System's Instructions for Use (IFU) to reduce the risk of air embolism during use.
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