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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 (4.0 MM)
Generic NameCoronary drug-eluting stent
ApplicantCordis Corp.
6500 Paseo Padre Pkwy.
Fremont, CA 94555
PMA NumberP020026
Supplement NumberS026
Date Received07/25/2006
Decision Date02/22/2011
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 4.0MM CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTORRAIL (RX) DELIVERY SYSTEM. THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME 4.00MM CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO LESIONS OF LENGTH <= 30 MM IN NATIVE CORONARY ARTERIES WITH A REFERENCE VESSEL DIAMETER OF >= 2.25 TO <= 4.0 MM.
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