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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.
 
DevicePROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corp.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP110010
Supplement NumberS053
Date Received04/25/2013
Decision Date11/21/2013
Product Code NIQ 
Advisory Committee Cardiovascular
Clinical TrialsNCT01703000
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE FOLLOWING CHANGES TO THE PROMUS® ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM-CHROMIUM CORONARY STENT SYSTEM: 1)STENT DESIGN MODIFICATIONS TOINCREASE AXIAL STRENGTH; 2) A SHORTER TIP AND COLORANT CHANGE ON THE STENT DELIVERY SYSTEM; 3) MODIFICATIONS TO THE HYPOTUBE COVERING ON THE STENT DELIVERY SYSTEM; AND 4) LABELING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM.
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