BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Iliac Covered Stent, Arterial

    PMA: P160021 · Supplement: S041 · Decision Jul 5, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Iliac Covered Stent, Arterial
    Trade Name
    GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
    PMA Number
    P160021
    Supplement Number
    S041
    Device Class
    FDA Class 3
    Product Code
    PRL
    Generic Name
    Iliac covered stent, arterial
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 5, 2023
    Date Received
    June 27, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Implementation of an alternate supplier of the outer foil packaging of the following devices: GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface, GORE VIABAHN VBX Balloon Expandable Endoprosthesis and GORE TAG Thoracic Branch 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