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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
Classification Namecoronary drug-eluting stent
ApplicantCORDIS CORPORATION
PMA NumberP020026
Supplement NumberS040
Date Received08/08/2007
Decision Date09/04/2007
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Use of cypher otw stents for analytical testing performed prior to release into finished goods inventory and for the reserve samples for both the cypher sirolimus-eluting coronary stent rapid exchange (rx) and over-the-wire (otw) delivery systems.
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