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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceWATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY
Classification Namesystem, appendage closure, left atrial
Generic Namesystem, appendage closure, left atrial
Applicant
Boston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
PMA NumberP130013
Date Received05/14/2013
Decision Date03/13/2015
Product Code
NGV[ Registered Establishments with NGV ]
Docket Number 15M-0910
Notice Date 03/13/2015
Advisory Committee Cardiovascular
Clinical Trials NCT00129545
NCT00851578
NCT01182441
NCT01196897
NCT01760291
Expedited Review Granted? Yes
Combination Product No
Recalls CDRH Recalls
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 
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