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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 (LAAC) Device with Delivery System
Generic NameSystem, appendage closure, left atrial
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP130013
Supplement NumberS057
Date Received02/03/2023
Decision Date09/06/2023
Product Code NGV 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for design modifications to the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device including the addition of a 40 mm device size, addition of radiopaque markers, and a device coating.
Post-Approval StudyShow Report Schedule and Study Progress
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