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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 Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Closure D
Generic NameSystem, appendage closure, left atrial
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP130013
Supplement NumberS070
Date Received06/27/2024
Decision Date09/23/2024
Product Code NGV 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for replacing a manual inspection with an automated inspection method, including modified acceptance criteria, to detect bent struts on the device frame for WATCHMAN FLX™ LAA Closure Device and WATCHMAN FLX™ Pro LAA Closure Device.
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