BEUDAMED
    FDA PMA 30-Day Notice Accepted 🇺🇸 United States

    PMA: P250017 · Supplement: S003 · Decision Apr 30, 2026
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    Basic Information

    Trade Name
    GORE® VIABAHN® FORTEGRA Venous Stent
    PMA Number
    P250017
    Supplement Number
    S003
    Product Code
    QTL
    Generic Name
    Stent, vena cava
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 30, 2026
    Date Received
    April 7, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    the addition of a second (internal) supplier for a trailing catheter subassembly