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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
Generic NameCoronary drug-eluting stent
ApplicantCordis Corp.
6500 Paseo Padre Pkwy.
Fremont, CA 94555
PMA NumberP020026
Supplement NumberS025
Date Received07/17/2006
Decision Date08/25/2006
Withdrawal Date08/28/2020
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO ELIMINATE THE COMMITMENT TO IMPLEMENT/CONDUCT ELUTION METHODOLOGY (CURRENT METHOD 10116481) AND SPECIFICATIONS.
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