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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 RAPTOR OVER-THE-WIRE DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTE
Generic NameCoronary drug-eluting stent
ApplicantCordis Corp.
6500 Paseo Padre Pkwy.
Fremont, CA 94555
PMA NumberP020026
Supplement NumberS059
Date Received12/08/2008
Decision Date05/27/2011
Withdrawal Date08/28/2020
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE XTEND MANUFACTURING PROCESS AND AN EXTENSION OF YOUR APPROVED SHELF LIFE FROM 3 TO 6 MONTHS.
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