BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

    PMA: P180014 · Supplement: S001 · Decision Oct 29, 2019
    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
    S001
    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
    October 29, 2019
    Date Received
    May 28, 2019
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the protocol for the post-approval study (PAS) protocol.

    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