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: S012 · Decision Oct 27, 2023
    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
    OrganOx metra System
    PMA Number
    P200035
    Supplement Number
    S012
    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
    October 27, 2023
    Date Received
    September 28, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    approval for an amendment to the OrganOx metra New Enrollment PAS (P200035/PAS003) protocol to include a study arm with the goal of collecting data on livers from DCD donors older than 40 years of age, perfused with the OrganOx metra and transplanted in adult recipients

    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