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: S012 · Decision May 9, 2023
    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
    S012
    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 9, 2023
    Date Received
    March 6, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change to the wireless monitor of the OCS Lung System, including replacing the obsolete display panel with an updated panel, replacing the existing CCFL backlight driver with an LED backlight driver, updating the Wireless Monitor PCBA with minor component updates.

    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