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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM(OVER-THE-WIRE& MONORAIL)
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corporation
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP150003
Supplement NumberS003
Date Received12/07/2015
Decision Date07/29/2016
Product Code NIQ 
Docket Number 16M-2334
Notice Date 08/18/2016
Advisory Committee Cardiovascular
Clinical TrialsNCT01665053
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail™ and Over-The-Wire). This device is indicated for improving luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries >=2.25 mm to <=4.00 mm in diameter in lesions <=34 mm in length.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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