BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P250017 · Decision Dec 19, 2025
    View on FDA
    Classifications
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    FEI Numbers
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    Registration Numbers
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    Basic Information

    Trade Name
    GORE® VIABAHN® FORTEGRA Venous Stent
    PMA Number
    P250017
    Product Code
    QTL
    Generic Name
    Stent, vena cava
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 19, 2025
    Date Received
    June 20, 2025
    Expedited Review
    N

    Advisory Committee 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.