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: S035 · Decision Mar 30, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    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
    S035
    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
    March 30, 2026
    Date Received
    December 31, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    approval for updated labeling (instructions for use, patient brochure, quick reference guide, training videos, and marketing materials (corporate brochure, surgeon brochure, and corporate overview)

    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