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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP060008
Supplement NumberS067
Date Received02/14/2011
Decision Date08/12/2011
Withdrawal Date12/06/2018
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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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