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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 PLACE
MAPLE GROVE, MN 55311-1566
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
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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