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

    Lithotriptor, Extracorporeal Shock-Wave, Urological

    PMA: P840008 · Supplement: S061 · Decision Nov 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Lithotriptor, Extracorporeal Shock-Wave, Urological
    Trade Name
    DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)
    PMA Number
    P840008
    Supplement Number
    S061
    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 3, 1997
    Date Received
    October 21, 1997
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to offer the Dornier X-ray Imaging Module, the Extended Image Stoarage component, and an alterantive electrocardiogram monitor as options ofor your device. In addition, the Advance Technology Laboratories ultrasound system will no longer be an option on your device. Finall, the wording of your precaution on hypertension has been modified as requested by FDA after our review of your postapproval study results.

    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