BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lithotripter, Shockwave (For Treating Gallbladder Stones)

    PMA: P970042 · Supplement: S004 · Decision Jan 28, 2003
    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 FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES
    PMA Number
    P970042
    Supplement Number
    S004
    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
    January 28, 2003
    Date Received
    August 2, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) A CHANGE IN THE INCLUSION AGE LIMIT FOR THE POST-APPROVAL STUDY FROM 18-70 TO 18 AND OVER; 2) A CHANGE IN THE POST APPROVAL STUDY'S MONITORING FROM RSI TO MEDSTONE; AND 3) A CHANGE IN THE POST-APPROVAL STUDY'S MEDICAL MONITOR FROM RSI TO MICHAEL ALBERT, M.D.

    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)