BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Oxygen, Aqueous

    PMA: P170027 · Supplement: S005 · Decision Jun 1, 2021
    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
    S005
    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
    June 1, 2021
    Date Received
    March 23, 2021
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at ZOLL Circulation Facility (2000 Ringwood Ave, San Jose, CA, 95131) for the final assembly, testing, final acceptance, and pack-out activities of the TherOx® DownStream® System Console only.

    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