BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

    PMA: P180014 · Supplement: S008 · Decision May 9, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
    Trade Name
    XVIVO Perfusion System (XPS) with STEEN Solution Perfusate
    PMA Number
    P180014
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    PHO
    Generic Name
    Normothermic preservation system for transplantation of initially unacceptable donor lungs
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 9, 2022
    Date Received
    February 8, 2022
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a software upgrade in the XPS (software v5.3.0) to address minor bug fixes and to remove the software control of XPS’ auxiliary pumps.

    Classifications

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

    Product Code Device Name
    PHO Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs