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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® FORTEGRA Venous Stent
Generic NameStent, vena cava
ApplicantW. L. Gore & Associates, Inc.
1505 N Fourth St.
Flagstaff, AZ 86004
PMA NumberP250017
Date Received06/20/2025
Decision Date12/19/2025
Product Code QTL 
Advisory Committee Cardiovascular
Clinical TrialsNCT05409976
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The GORE® VIABAHN® FORTEGRA Venous Stent is indicated for use in the treatment of symptomatic inferior vena cava obstruction with or without combined iliofemoral obstruction.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 
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