BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

    PMA: P180014 · Supplement: S011 · Decision Sep 20, 2024
    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
    XPS with Steen Solution Perfusate
    PMA Number
    P180014
    Supplement Number
    S011
    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
    September 20, 2024
    Date Received
    June 20, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for change from a leucocyte filter to an arterial filter, Medtronic Affinity™ AF100 Arterial Filter (K122760).

    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