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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
Generic NameSystem, appendage closure, left atrial
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP130013
Supplement NumberS052
Date Received09/28/2022
Decision Date05/11/2023
Product Code NGV 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to add an alternative imaging modality option, intracardiac echocardiography (ICE), to the Instructions for Use (IFU) for use during the implant procedure. Additionally, you proposed updating the IFU with new clinical data, updating the Indications for Use to align with current practice, as well as streamline the IFU, Pouch Label, Spine Label, Carton Label, Patient Guide and Patient Implant Card in accordance with current labeling procedures.
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