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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 NumberS036
Date Received05/21/2007
Decision Date06/20/2007
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Addition of a "tip rounding" step to the crimp and pack unit manufacturing operation and update of the visual quality standard requirements for the catheter distal tip.
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