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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.
 
DeviceSYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Generic NameCoronary drug-eluting stent
ApplicantBOSTON SCIENTIFIC CORPORATION
One Scimed Place
Maple Grove, MN 55311
PMA NumberP150003
Date Received01/15/2015
Decision Date10/02/2015
Product Code NIQ 
Docket Number 15M-4014
Notice Date 11/02/2015
Advisory Committee Cardiovascular
Clinical TrialsNCT01665053
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE, STABLEANGINA, UNSTABLE ANGINA, NON-ST ELEVATION MI OR DOCUMENTED SILENT ISCHEMIA DUE TO ATHEROSCLEROTIC LESIONS IN NATIVE CORONARY ARTERIES >=2.25 MM TO <=4.0 MM IN DIAMETER IN LESIONS <=34 MM IN LENGTH.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S004 S009 S010 S011 S012 S013 S014 S015 S016 S017 
S018 S019 S027 S029 S002 S003 S005 S006 S007 S021 S022 S023 
S024 S008 S030 S031 S028 S025 S026 S020 S035 S036 S040 S038 
S055 S056 S063 S048 S049 S050 S059 S060 S078 S073 S074 S084 
S091 S092 S093 S094 S096 S033 S034 S041 S042 S037 S039 S032 
S051 S065 S047 S046 S057 S058 S061 S062 S070 S052 S053 S054 
S043 S044 S045 S064 S080 S081 S088 S089 S090 S098 S095 S066 
S067 S068 S069 S075 S076 S077 S071 S072 S083 S079 S085 S086 
S087 S097 
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