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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 STENTS
Generic NameCoronary drug-eluting stent
ApplicantCordis Corp.
6500 Paseo Padre Pkwy.
Fremont, CA 94555
PMA NumberP020026
Supplement NumberS050
Date Received03/05/2008
Decision Date03/23/2009
Withdrawal Date08/28/2020
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE OF THE TRANSFER OF STENT TRAYS DURING THE SPRAY COATING UNIT OPERATION FROM THE CURRENT METHODOLOGY TO A CONTINUOUS MANNER FROM THE COATING STEP TO ANOTHER.
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