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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTE
Classification Namecoronary drug-eluting stent
Generic Namedrug-eluting stent
ApplicantCORDIS CORPORATION
PMA NumberP020026
Supplement NumberS059
Date Received01/08/2009
Decision Date05/27/2011
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product Yes
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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