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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 NumberS011
Date Received02/02/2009
Decision Date07/13/2009
Withdrawal Date12/06/2018
Product Code NIQ 
Docket Number 09M-0369
Notice Date 08/04/2009
Advisory Committee Cardiovascular
Clinical TrialsNCT00371478
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO EXPAND THE PRODUCT MATRIX TO INCLUDE THE 38 MM LENGTH TAXUS LIBERTÉ PACLITAXEL-ELUTING CORONARY STENT SYSTEM. THE DEVICE SIZE WILL BE MARKETED UNDER THE TRADE NAME TAXUS LIBERTÉ LONG PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS), AND IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.75 MM TO <=4.00 MM IN DIAMETER IN LESIONS <=34 MM IN LENGTH.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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