BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Oxygen, Aqueous

    PMA: P170027 · Supplement: S002 · Decision Mar 11, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    System, Oxygen, Aqueous
    Trade Name
    TherOx Downstream System
    PMA Number
    P170027
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    MWG
    Generic Name
    System, oxygen, aqueous
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 11, 2020
    Date Received
    August 19, 2019
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the DS-2 Console. The DS-2 Console uses the same cartridge as the DS-1 Console; however, it has updated hardware and software to accommodate a touchscreen display in addition to modified electrical components to comply with the EU RoHS Standard.

    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