BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Shunt, Portosystemic, Endoprosthesis

    PMA: P040027 · Supplement: S095 · Decision Feb 7, 2024
    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
    Supplement Number
    S095
    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
    February 7, 2024
    Date Received
    January 8, 2024
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    approval for updates to the Instructions for Use (IFU) of the GORE VIATORR TIPS Endoprosthesis with Controlled Expansion, including the following: • clarifications to the Warnings and Precautions section;• changes made to comply with the requirements of ISO 14971:2019-Application of risk management to medical devices; • changes made to comply with the 2023 FDA guidance on ‘Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment’.

    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