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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 Left Atrial Appendage Closure (LAAC) Device with Delivery System
Generic NameSystem, appendage closure, left atrial
ApplicantBoston Scientific Corp.
MAPLE GROVE, MN 55311-1566
PMA NumberP130013
Supplement NumberS046
Date Received08/26/2021
Decision Date09/09/2021
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  
Modification to the implant frame measurement system software used for dimensional inspection.