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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.
 
DeviceVERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
One Scimed Place
Maple Grove, MN 55311
PMA NumberP040016
Date Received03/26/2004
Decision Date04/12/2005
Withdrawal Date 12/06/2018
Product Code MAF 
Docket Number 05M-0192
Notice Date 05/18/2005
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE BOSTON SCIENTIFIC CORPORATION LIBERTE MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS. THE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE WITH STENOTIC LESIONS IN NATIVE CORONARY ARTERIES (LENGTH <=28 MM) WITH A REFERENCE VESSEL DIAMETER OF 2.75 TO 5.00 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 
S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S026 
S027 S028 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 S059 S060 S061 S062 
S063 S064 S065 S066 S067 S068 S069 S070 S071 S072 S073 S074 
S075 S076 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 S103 S104 S105 S106 S107 S108 S110 S113 S114 
S115 S116 S117 S118 S119 S120 S121 S122 S123 S124 S125 S126 
S127 S128 S129 S130 S131 S132 S134 
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