BEUDAMED
    FDA PMA Approved (Reclassification) 🇺🇸 United States

    PMA: P920051 · Supplement: S002 · Decision Dec 11, 1995
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    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    STORZ MODULITH (TM) LITHOTRIPTER
    PMA Number
    P920051
    Supplement Number
    S002
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    December 11, 1995
    Date Received
    September 18, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING DEVICE MODIFICATIONS: 1)INCLUSION OF AN UPGRADED VIDEO MIXER; 2) MODIFICATION OF THE WATER CIRCUIT TO INCLUDE PRESSURE FEEDBACK; 3) REPLACEMENT OF THE NYLON/ALUMINUM PATIENT TABLE WITH A CARBON FIBER MODEL; 4) ADDITION OF THE FVP-30 X-RAY IMAGE PROCESSING FEATURE (WHICH ALSO INCLUDED REVISIONS OT THE X-RAY OPERATOR'S AND SERVICE MANUALS)