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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 Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl
Generic NameSystem, appendage closure, left atrial
ApplicantBoston Scientific Corp.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP130013
Supplement NumberS062
Date Received10/13/2023
Decision Date11/09/2023
Product Code NGV 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
approval to transfer sub-assembly manufacturing processes for the WATCHMAN FLX and WATCHMAN FLX Pro devices to the BSC Galway, Ireland manufacturing site
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