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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceWATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY
Generic Namesystem, appendage closure, left atrial
ApplicantBoston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
PMA NumberP130013
Date Received05/14/2013
Decision Date03/13/2015
Product Code NGV 
Docket Number 15M-0910
Notice Date 03/13/2015
Advisory Committee Cardiovascular
Clinical TrialsNCT00129545
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S022 S023 S024 
S025 S026 S027 S028 S029 S030 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 
S050 S051 S054 S055 
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