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

    Lithotriptor, Extracorporeal Shock-Wave, Urological

    PMA: P840008 · Supplement: S065 · Decision Jul 7, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Lithotriptor, Extracorporeal Shock-Wave, Urological
    Trade Name
    DORNIER COMPACT DELTA
    PMA Number
    P840008
    Supplement Number
    S065
    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 7, 1998
    Date Received
    June 25, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes tot he therapy head movement capabilities, alteration of the hand held control unit, modification of the X-ray range of movement, addition of an X-ray image storage feature, ECG monitor model replacement, replacement of the charging unit, a new mounting orientation for the ultrasound arm, design changes to the patient table, a new design for the phantom support accessory, software modifications, and labeling changes. The device, as modified, will be marketed under the trade name Dornier Compact Delta Lithotripter and is indicated for fragmentation of 5 to 25 millimeter kidney stones such as renal calyx stones and renal pelivc stones.

    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