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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 Pl.
Maple Grove, MN 55311
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
Predetermined Change Control Plan AuthorizedNo
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: S017 S018 S019 S020 S032 S033 S035 S040 S041 S028 S022 S023 
S024 S025 S034  S038 S036 S026 S055 S056 S047 S048 S077 
S062 S063 S064 S065 S070 S083 S085 S009 S010 S013 S007 S008 
S014 S011 S016 S015 S027 S037 S039 S029 S030 S057 S042 S043 
S045 S046 S069 S075 S076 S066 S071 S072 S059 S060 S002 S049 
S050 S051 S044 S052 S053 S054 S003 S004 S005 S001 S058 S012 
S006 S080 S081 S074 S082 S067 S068 S078 S079 
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