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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameWATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY
Classification Namesystem, appendage closure, left atrial
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP130013
Date Received05/14/2013
Decision Date03/13/2015
Product Code
NGV[ Registered Establishments with NGV ]
Advisory Committee Cardiovascular
Clinical Trials NCT00129545
NCT00851578
NCT01182441
NCT01196897
NCT01760291
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the watchman laa closure technology. This device is indicated to reduce the risk of thromboembolism from the left atrial appendage (laa) in patients with non-valvular atrial fibrillation who: ¿ are at increased risk for stroke and systemic embolism based on chads2 or cha2ds2-vasc scores and are recommended for anticoagulation therapy; ¿ are deemed by their physicians to be suitable for warfarin; and ¿ have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.
Approval Order Approval Order
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