Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 Pl.
Maple Grove, MN 55311
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
Predetermined Change Control Plan AuthorizedNo
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.
-
-