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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.
 
DeviceCYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE WIRE DELIVERY
Generic NameCoronary drug-eluting stent
ApplicantCordis Corp.
6500 Paseo Padre Pkwy.
Fremont, CA 94555
PMA NumberP020026
Supplement NumberS013
Date Received05/05/2005
Decision Date06/06/2005
Withdrawal Date08/28/2020
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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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