BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

    PMA: P200031 · Supplement: S007 · Decision Jan 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
    Trade Name
    Organ Care System (OCS™) Liver
    PMA Number
    P200031
    Supplement Number
    S007
    Device Class
    FDA Class 3
    Product Code
    QQK
    Generic Name
    Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 13, 2025
    Date Received
    July 18, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the implementation of an alternative oxygenator, identified as the Maquet Quadrox-i, for the Organ Care System Liver

    Classifications

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

    Product Code Device Name
    QQK Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation