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

    Lithotriptor, Extracorporeal Shock-Wave, Urological

    PMA: P970019 · Decision Jul 21, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Lithotriptor, Extracorporeal Shock-Wave, Urological
    Trade Name
    HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM
    PMA Number
    P970019
    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
    July 21, 1997
    Date Received
    May 16, 1997
    Expedited Review
    N
    Docket Number
    97M-0453

    Advisory Committee Statement

    APPROVAL FOR THE LITHOTRON(TM) LITHOTRIPSY SYSTEM. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WITH RENAL AND UPPER URETERAL CALCULI BETWEEN 4 AND 20 MM 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