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

    Lithotriptor, Extracorporeal Shock-Wave, Urological

    PMA: P870015 · Supplement: S034 · Decision Nov 19, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Lithotriptor, Extracorporeal Shock-Wave, Urological
    Trade Name
    TRANSPORTABLE MODEL STS-T LITHOTRIPTER
    PMA Number
    P870015
    Supplement Number
    S034
    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
    November 19, 1999
    Date Received
    November 16, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for minor changes to the hardware (i.e., modification to the remote control, addition of a foot switch, increase in the travel distance of the shockwave positionere, and modification to the printed circuit board that interfaces the computer with the axis controllers) and software (i.e., upgrade to version 1999.3), as well as minor changes tot he device's labeling.

    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