BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Shunt, Portosystemic, Endoprosthesis

    PMA: P040027 · Decision Dec 6, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Shunt, Portosystemic, Endoprosthesis
    Trade Name
    GORE VIATORR TIPS
    PMA Number
    P040027
    Device Class
    FDA Class 3
    Product Code
    MIR
    Generic Name
    SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 6, 2004
    Date Received
    June 9, 2004
    Expedited Review
    Y
    Docket Number
    06M-0411

    Advisory Committee Statement

    APPROVAL FOR THE GORE VIATORR TIPS ENDOPROSTHESIS. THE DEVICE IS INDICATED FOR USE IN DE NOVO AND REVISION TREATMENT OF PORTAL HYPERTENSION AND ITS COMPLICATIONS SUCH AS VARICEAL BLEEDING, GASTROPATHY, ASCITES, AND/OR HEPATIC HYDROTHORAX.

    Classifications

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

    Product Code Device Name
    MIR Shunt, Portosystemic, Endoprosthesis