BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Oxygen, Aqueous

    PMA: P170027 · Supplement: S017 · Decision Dec 19, 2024
    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
    S017
    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
    December 19, 2024
    Date Received
    November 25, 2024
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for additional inspection step in the manufacturing process approval for the Cartridge Chambers and Cartridge Oxygen Port Filter.

    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