BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P200035 · Supplement: S036 · Decision Apr 10, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
    Trade Name
    OrganOx metra® System
    PMA Number
    P200035
    Supplement Number
    S036
    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
    April 10, 2026
    Date Received
    March 13, 2026
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    including additional bioburden and bacterial endotoxin testing for the oxygenator component of the D0146/D0146-US Disposable Set

    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