BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

    PMA: P180014 · Supplement: S013 · Decision Nov 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    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
    S013
    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
    November 25, 2025
    Date Received
    August 27, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for material changes to the organ chamber elbow fitting and the lung cannula set luer connector

    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