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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.
 
DeviceVIABAHN ENDOPROSTHESIS
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantW.L. GORE & ASSOCIATES,INC
3450 WEST KILTIE LN.
P.O. BOX 500
FLAGSTAFF, AZ 86002-0500
PMA NumberP040037
Date Received08/27/2004
Decision Date06/14/2005
Product Code NIP 
Docket Number 05M-0379
Notice Date 09/23/2005
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE GORE VIABAHN ENDOPROSTHESIS. THE DEVICE IS INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN SUPERFICIAL FEMORAL ARTERY LESIONS WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.8 TO 7.5 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S002 S003 S004 S005 S006 S007 S009 S010 S011 S012 S013 
S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 
S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S042 S043 S044 S045 S046 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 S077 S079 S080 S081 S082 S083 S084 S085 S086 S087 
S088 S089 S090 S091 S092 S093 S094 S095 S096 S097 S099 S100 
S101 S102 S103 S104 S105 S106 S107 S108 S109 S110 S111 S112 
S114 S115 S116 S117 S118 S119 S120 S121 S122 S123 S124 S125 
S126 S127 S128 S129 S130 S131 S132 S133 S134 S135 S136 S137 
S138 S139 S140 S141 S143 S144 S145 S146 S147 S148 S149 S150 
S151 S152 S153 S154 S155 S156 S157 S158 S159 S160 S161 S162 
S163 S164 
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