BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P250017 · Supplement: S001 · Decision Apr 7, 2026
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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
    Supplement Number
    S001
    Product Code
    QTL
    Generic Name
    Stent, vena cava
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 7, 2026
    Date Received
    January 21, 2026
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the protocol for the new enrollment post-approval study (PAS)