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

    System, Oxygen, Aqueous

    PMA: P170027 · Supplement: S016 · Decision Dec 11, 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
    S016
    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
    December 11, 2024
    Date Received
    November 18, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    partial relocation of Catheter manufacturing process steps and process improvement in current bioburden monitoring process

    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