BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Lithotriptor, Extracorporeal Shock-Wave, Urological

    PMA: P970019 · Supplement: S004 · Decision Sep 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Lithotriptor, Extracorporeal Shock-Wave, Urological
    Trade Name
    LITHOTRON ULTRA LITHOSTRIPSY SYSTEM
    PMA Number
    P970019
    Supplement Number
    S004
    Device Class
    FDA Class 2
    Product Code
    LNS
    Generic Name
    Lithotriptor, extracorporeal shock-wave, urological
    Regulation Number
    876.5990
    Medical Specialty
    Gastroenterology, Urology
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    September 11, 1998
    Date Received
    August 27, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the following modifications to the LithoTron(TM) Lithotripsy System: 1) replacement of the transportable C-arm fluoroscopy system with an upgraded, stationary x-ray imaging system, 2) replacement of the existing patient table with one that offers Trendelenburg positioning, and 3) the addition of motorized movement of the shock wave therapy head. The device is indicated for use in patients with renal and upper ureteral calculi between 4mm and 20mm in size.

    Classifications

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

    Product Code Device Name
    LNS Lithotriptor, Extracorporeal Shock-Wave, Urological