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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
Generic Namecoronary drug-eluting stent
Applicant
Boston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
PMA NumberP060008
Date Received03/08/2006
Decision Date10/10/2008
Withdrawal Date 12/06/2018
Product Code NIQ 
Docket Number 08M-0593
Notice Date 11/14/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
RecallsCDRH Recalls
Approval Order Statement 
APPROVAL FOR THE TAXUS LIBERTÉ PACLITAXEL-ELUTING CORONARY STENT SYSTEM. THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS <= 28 MM IN LENGTH IN NATIVE CORONARY ARTERIES >= 2.5 MM TO <= 4.0 MM IN DIAMETER.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 
S009 S010 S011 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 S025 S026 S027 
S029 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S042 S043 S044 S045 S046 
S047 S048 S049 S050 S051 S052 S053 S054 S055 
S056 S057 S058 S060 S061 S062 S063 S064 S065 
S066 S067 S068 S069 S070 S071 S072 S073 S074 
S075 S077 S078 S079 S080 S081 S082 S083 S084 
S085 S086 S087 S088 S089 S090 S091 S092 S093 
S094 S095 S096 S097 S098 S099 S100 S101 S102 
S104 S105 S106 S107 S108 
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