BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lithotripter, Shockwave (For Treating Gallbladder Stones)

    PMA: P970042 · Supplement: S001 · Decision Feb 5, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Lithotripter, Shockwave (For Treating Gallbladder Stones)
    Trade Name
    MEDSTONE STS LITHOTRIPTER
    PMA Number
    P970042
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    NCV
    Generic Name
    Lithotripter, shockwave (for treating gallbladder stones)
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 5, 2001
    Date Received
    December 18, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR SEVERAL CHANGES TO THE POST-APPROVAL STUDY PROTOCOL. SPECIFICALLY, THESE CHANGES ARE 1) CHANGES TO INCLUSION CRITERIA 3 AND 5 2) CHANGES TO EXCLUSION CRITERIA 7, 8, 9, 10, 11, 13, 15, AND 16 3) ELIMINATION OF THE ULTRASOUND EVALUATION IMMEDIATELY POST-LITHOTRIPSY, 4) ELIMINATION OF THE ORAL CHOLECYSTOGRAM AT THE SIX-MONTH VISIT, AND 5) ADDITION OF STATEMENTS TO CLARIFY GUIDELINES FOR SCHEDULING FOLLOW-UP VISITS AND TO LIST PROTOCOL REQUIREMENTS BY STUDY VISIT.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NCV Lithotripter, Shockwave (For Treating Gallbladder Stones)