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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
ApplicantMAQUET CARDIOVASCULAR LLC
PMA NumberP060008
Supplement NumberS097
Date Received09/07/2012
Decision Date05/01/2013
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the labeling update for the taxus liberté paclitaxel-eluting coronary stent system.
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