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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™ Left Atrial Appendage (LAA) Closure Device with Delivery System; WATCHMAN FLX™ Pro Left Atrial Appendage (
Generic NameSystem, appendage closure, left atrial
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP130013
Supplement NumberS080
Date Received10/07/2025
Decision Date12/12/2025
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 a Gantry-assisted Wetline process as alternative to the current electropolishing processes for WATCHMAN FLX™ and WATCHMAN FLX™ Pro Left Atrial Appendage (LAA) Closure Devices with Delivery Systems
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