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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 (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli
Generic NameSystem, appendage closure, left atrial
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP130013
Supplement NumberS074
Date Received01/17/2025
Decision Date07/16/2025
Product Code NGV 
Advisory Committee Cardiovascular
Clinical TrialsNCT02699957
Supplement TypePanel 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 for expanding the indications to include patients following catheter ablation for non-valvular atrial fibrillation and to add a new post-implant drug regimen to the device labeling. The WATCHMAN FLX™ Device and the WATCHMAN FLX™ Pro Device are indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who:•Are at increased risk for stroke and systemic embolism based on CHA2DS2-VASc1 scores and are recommended for anticoagulation therapy;•Are deemed by their physicians to be suitable for anticoagulation therapy; and•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.Following catheter ablation for non-valvular atrial fibrillation (concomitantly or sequentially with WATCHMAN FLX™ or WATCHMAN FLX™ Pro implantation): The WATCHMAN FLX™ and WATCHMAN FLX™ Pro devices are indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who:•Are at increased risk for stroke and systemic embolism based on CHA2DS2-VASc1 scores and are recommended for anticoagulation therapy;•Are deemed by their physicians to be suitable for 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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