BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    System, Oxygen, Aqueous

    PMA: P170027 · Supplement: S010 · Decision Oct 27, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    System, Oxygen, Aqueous
    Trade Name
    TherOx Downstream Console
    PMA Number
    P170027
    Supplement Number
    S010
    Device Class
    FDA Class 3
    Product Code
    MWG
    Generic Name
    System, oxygen, aqueous
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 27, 2022
    Date Received
    September 30, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Supplier change of the TherOx® DownStream® Console Model DS-2 sub-assemblies due to impacts from COVID-19 pandemic.

    Classifications

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

    Product Code Device Name
    MWG System, Oxygen, Aqueous