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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
Classification Namecoronary drug-eluting stent
Generic Namedrug eluting stent
ApplicantCORDIS CORPORATION
PMA NumberP020026
Supplement NumberS013
Date Received05/05/2005
Decision Date06/06/2005
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for labeling changes to better inform patients and health care providers about the risks of early discontinuation of antiplatelet therapy and that responds to a letter sent to cordis by fda dated april 21, 2005.
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