BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Shunt, Portosystemic, Endoprosthesis

    PMA: P040027 · Supplement: S054 · Decision Mar 22, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Shunt, Portosystemic, Endoprosthesis
    Trade Name
    GORE VIATORR TIPS ENDOPROSTHESIS
    PMA Number
    P040027
    Supplement Number
    S054
    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
    March 22, 2017
    Date Received
    January 18, 2017
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the following modifications to the Instructions for Use (IFU): 1) to include the GORE® TIPS Sheath as an additional recommended accessory; and 2) to revise the post-placement management instructions.

    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