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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 SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER
Generic NameCoronary drug-eluting stent
ApplicantCORDIS CORP.
6500 Paseo Padre Parkway
Fremont, CA 94555
PMA NumberP020026
Supplement NumberS003
Date Received06/23/2003
Decision Date10/10/2003
Withdrawal Date 08/28/2020
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
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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