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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 FLXTM Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLXTM Pro Left Atrial Appendage Closu
Generic NameSystem, appendage closure, left atrial
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP130013
Supplement NumberS085
Date Received04/06/2026
Decision Date04/23/2026
Product Code NGV 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
to add an alternate broken strut inspection system for the WATCHMAN FLX™ Left Atrial Appendage (LAA) Closure Device with Delivery System and WATCHMAN FLX™ Pro LAA Closure Device with Delivery System
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