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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.
 
DeviceGORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Generic NameSystem, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
ApplicantW.L. GORE & ASSOCIATES,INC
3250 W.KILTIE LANE
FLAGSTAFF, AZ 86001
PMA NumberP130006
Date Received04/01/2013
Decision Date12/05/2013
Product Code PFV 
Docket Number 13M-1605
Notice Date 12/24/2013
Advisory Committee Cardiovascular
Clinical TrialsNCT00737672
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE GORE VIABAHN ENDOPROSTHESIS AND THE GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. THIS DEVICE IS INDICATED FOR THE TREATMENT OF STENOSIS OR THROMBOTIC OCCLUSION AT THE VENOUS ANASTOMOSIS OF SYNTHETIC ARTERIOVENOUS (AV) ACCESS GRAFTS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S018 S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 
S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 
S050 S051 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 S078 S079 S080 S082 S083 S084 S085 S086 S087 
S088 S089 S090 S091 S092 S093 S094 S095 S096 S097 S098 S099 
S100 S101 S102 S103 
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