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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 ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER
Classification Namecoronary drug-eluting stent
Generic Namedrug eluting stent
ApplicantCORDIS CORPORATION
PMA NumberP020026
Supplement NumberS003
Date Received06/27/2003
Decision Date10/10/2003
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 the addition of a second identity method for rapamycin in cypher sirolimus-eluting coronary stents. This method will be performed in conjunction with the currently approved identity method. The addition of the second identity method is in accordance with one of the conditions of approval commitments made for this pma.
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