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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.
 
DeviceCORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT
Generic NameCoronary drug-eluting stent
ApplicantCORDIS CORP.
6500 Paseo Padre Parkway
Fremont, CA 94555
PMA NumberP020026
Supplement NumberS010
Date Received01/20/2004
Decision Date04/15/2005
Withdrawal Date 08/28/2020
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE CYPHER SIROLIMUS-ELUTING CORONARY STENT SYSTEM (CYPHER STENT) INSTRUCTIONS FOR USE (IFU).
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