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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCYPHER SIROLIMUS-ELUTING CORONARY STENT
Classification Namecoronary drug-eluting stent
Generic Namedrug eluting stent
ApplicantCORDIS CORPORATION
PMA NumberP020026
Supplement NumberS004
Date Received06/27/2003
Decision Date04/13/2007
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a new elution test method and revised elution specifications.
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