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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
Generic NameSystem, appendage closure, left atrial
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP130013
Supplement NumberS083
Date Received02/03/2026
Decision Date02/12/2026
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  
introduction of an alternate radiopaque (RO) marker crimper system to be used in addition to the existing crimper system for manufacturing the WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System
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