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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 CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT
Generic NameCoronary drug-eluting stent
ApplicantCORDIS CORP.
6500 Paseo Padre Parkway
Fremont, CA 94555
PMA NumberP020026
Supplement NumberS083
Date Received03/21/2011
Decision Date05/27/2011
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 UPDATED MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY TESTING AND MRI CONDITIONS OF USE LABELING.
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