BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

    PMA: P160013 · Supplement: S009 · Decision May 6, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation
    Trade Name
    Organ Care System™ (OCS) Lung System
    PMA Number
    P160013
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    QBA
    Generic Name
    Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 6, 2022
    Date Received
    February 7, 2022
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of the Lung Small Trachea Cannula Set to the currently available trachea cannulas for the OCS Lung System.

    Classifications

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

    Product Code Device Name
    QBA Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation