BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lithotripter, Shockwave (For Treating Gallbladder Stones)

    PMA: P970042 · Supplement: S003 · Decision Feb 14, 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-TC/U LITHOTRIPTER
    PMA Number
    P970042
    Supplement Number
    S003
    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 14, 2003
    Date Received
    July 3, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE STS-TC/U LITHOTRIPTER (TRANSPORTABLE VERSION OF THE STS LITHOTRIPTER WITH ULTRASOUND). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDSTONE STS-TC/U LITHOTRIPTER AND IS INDICATED FOR 1) THE FRAGMENTATION OF SYMPTOMATIC UPPER URINARY TRACT STONES, I.E., RENAL CALYCEAL STONES, RENAL PELVIC STONES, AND UPPER URETERAL STONES, AND 2) WHEN USED IN CONJUNCTION WITH CERTAIN URSODIOLS, IS INDICATED FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES (BETWEEN 4 AND 20 MM IN MAXIMUM DIAMETER) IN ADULT 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)