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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 NameTAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP060008
Supplement NumberS067
Date Received02/14/2011
Decision Date08/12/2011
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for revised labeling to include updated clinical trial data through the final 5-year time point for the taxus atlas study and through three (3) years for the taxus atlas small vessel and long lesion studies.
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