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

    Lithotriptor, Extracorporeal Shock-Wave, Urological

    PMA: P920034 · Decision Sep 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Lithotriptor, Extracorporeal Shock-Wave, Urological
    Trade Name
    TRIPTER-X1 NOVA
    PMA Number
    P920034
    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 20, 1996
    Date Received
    July 9, 1992
    Expedited Review
    N
    Docket Number
    96M-0473

    Advisory Committee Statement

    APPROVAL FOR THE TRIPTER-X1 SERIES EXTRACORPOREAL SHOCK WAVE LITHOTRIPTERS (TRIPTER-X1, TRIPTER-X1 NOVA, AND TRIPTER-X1 COMPACT

    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