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

    Lithotriptor, Extracorporeal Shock-Wave, Urological

    PMA: P870015 · Supplement: S030 · Decision Sep 16, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Lithotriptor, Extracorporeal Shock-Wave, Urological
    Trade Name
    MEDSTONE STS-T TRANSPORTABLE LITHOTRIPTER
    PMA Number
    P870015
    Supplement Number
    S030
    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 16, 1998
    Date Received
    July 17, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a transportable configuration of the Medstone STS lithotripter. The devices, as modified, will be marketed under the trade name Medstone STS-T Transportable Lithotripter and is indicated for use in fragmentation of upper urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral 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