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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
Classification Namecoronary drug-eluting stent
Generic Namedrug-eluting coronary stent system
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP060008
Date Received03/08/2006
Decision Date10/10/2008
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 08M-0593
Notice Date 11/14/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
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 
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