BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Generator, Shock-Wave, For Pain Relief

    PMA: P080028 · Supplement: S001 · Decision Feb 5, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Generator, Shock-Wave, For Pain Relief
    Trade Name
    Storz Medical Duolith SD1 Shock Wave Therapy Device
    PMA Number
    P080028
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    NBN
    Generic Name
    Generator, shock-wave, for pain relief
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 5, 2020
    Date Received
    December 26, 2018
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for upgrading the power supply, controller, and Graphical User Interface software revision to accommodate new hardware, as well as the addition of an optional control module and ultrasound imaging unit/monitor.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NBN Generator, Shock-Wave, For Pain Relief