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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 and WATCHMAN Left Atrial Appendage Closure Device
Generic NameSystem, appendage closure, left atrial
ApplicantBoston Scientific Corp.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP130013
Supplement NumberS035
Date Received01/02/2020
Decision Date07/21/2020
Product Code NGV 
Docket Number 20M-1715
Notice Date 07/30/2020
Advisory Committee Cardiovascular
Clinical TrialsNCT02702271
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Left Atrial Appendage Closure Device with Delivery System. The supplement requested approval for a modified version of the WATCHMAN Left Atrial Appendage Closure Device with Delivery System referred to as the WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and to expand the indications to include anticoagulation therapy. These devices are indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who:1) Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy;2) Are deemed by their physicians to be suitable for anticoagulation therapy; and3) Have an appropriate rationale to seek a non-pharmacologic alternative to anticoagulation therapy, taking into account the safety and effectiveness of the device compared to anticoagulation therapy.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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