BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lithotripter, Shockwave (For Treating Gallbladder Stones)

    PMA: P970042 · Supplement: S002 · Decision Aug 20, 2002
    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
    S002
    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
    August 20, 2002
    Date Received
    February 21, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) THE USE OF TWO GENERIC URSODIOLS, ONE MANUFACTURED BY AMIDE PHARMACEUTICAL AND ONE BY TEVA PHARMACEUTICAL, IN ADDITION TO ACTIGALL; 2) A CHANGE IN THE POST-APPROVAL STUDY'S MEDICAL MONITOR TO JOAN L. DRUCKER M.D., R.S.I.; AND 3) SEVERAL MINOR CLARIFICATIONS, CORRECTIONS AND EDITORIAL CHANGES TO THE POST-APPROVAL STUDY PROTOCOL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME, MEDSTONE STS LITHOTRIPTER, AND IS INDICATED FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES (BETWEEN 4 AND 20 MM IN MAXIMUM DIAMETER) IN ADULTS PATIENTS FOR WHOM SURGICAL REMOVAL OF THE GALLBLADDER IS MEDICALLY CONTRAINDICATED AND IN SYMPTOMATIC HIGH-RISK PATIENTS WHO HAVE ACTIVELY REFUSED SURGERY. COMBINATION THERAPY CONSISTS OF 1)ADMINISTRATION OF NOVARTIS PHARMACEUTICAL ACTIGALL, OR AMIDE PHARMACEUTICAL URSODIOL, OR TEVA PHARMACEUTICAL URSODIOL (8-10 MG/KG/DAY) FOR AT LEAST TWO WEEKS PRE-LITHOTRIPSY, 2) LITHOTRIPSY TREATMENTS OF UP TO 2000 24 KV SHOCKS, AND 3) CONTINUED ADMINISTRATION OF URSODIOL UNTIL A STONE-FREE STATE IS ACHIEVED.

    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)