BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Iliac Covered Stent, Arterial

    PMA: P160021 · Supplement: S048 · Decision Nov 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Iliac Covered Stent, Arterial
    Trade Name
    GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
    PMA Number
    P160021
    Supplement Number
    S048
    Device Class
    FDA Class 3
    Product Code
    PRL
    Generic Name
    Iliac covered stent, arterial
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 24, 2025
    Date Received
    August 22, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a reduced profile balloon catheter delivery system and modified packaging for the 10 and 11mm diameter sizes of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PRL Iliac Covered Stent, Arterial