BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Oxygen, Aqueous

    PMA: P170027 · Supplement: S009 · Decision Mar 10, 2022
    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
    S009
    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 10, 2022
    Date Received
    December 17, 2021
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a new material plasticizer for the tubing associated with the TherOx SSO2 DownStream Cartridge, part of the TherOx Downstream System.

    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