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: S002 · Decision May 31, 2019
    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
    S002
    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 31, 2019
    Date Received
    August 14, 2018
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    19M-2671

    Advisory Committee Statement

    Approval for the Organ Care System (OCS™) Lung System. The TransMedics Organ Care System (OCS) Lung is a portable, normothermic organ perfusion, ventilation and monitoring medical device indicated for preservation of standard criteria donor lung pairs and for preservation of donor lung pairs initially deemed unacceptable for procurement and transplantation based on limitations of cold static preservation. The device allows for ex vivo assessment of donor lungs prior to transplantation.

    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