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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 VBX BALLOON EXPANDABLE ENDOPROSTHESIS
Generic NameIliac covered stent, arterial
ApplicantW. L. Gore & Associates, Inc.
3250 WEST KILTIE LANE
FLAGSTAFF, AZ 86005
PMA NumberP160021
Date Received07/05/2016
Decision Date01/27/2017
Product Code PRL 
Docket Number 16M-0560
Notice Date 02/27/2017
Advisory Committee Cardiovascular
Clinical TrialsNCT02080871
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5mm - 13mm and lesion lengths up to 110mm, including lesions at the aortic bifurcation.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S002 S003 S004 S005 S006 S008 S009 S010 S011 S012 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 
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