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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 NumberS075
Date Received02/04/2025
Decision Date05/05/2025
Product Code NGV 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for adding an alternative braiding method, including a component-level manufacturing process, design specification changes, and new visual standards used in inspection processes, for the manufacture of the insourced Delivery Sheath component of the WATCHMAN FLX ™ and WATCHMAN FLX Pro ™ Left Atrial Appendage (LAA) Closure Devices with Delivery Systems.
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