BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P030052 · Decision Jan 24, 2005
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    UROVYSION BLADDER CANCER KIT
    PMA Number
    P030052
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 24, 2005
    Date Received
    December 10, 2003
    Expedited Review
    N
    Docket Number
    05M-0130

    Advisory Committee Statement

    APPROVAL FOR THE UROVYSION BLADDER CANCER KIT. THE DEVICE IS INDICATED FOR: THE UROVYSION BLADDER CANCER KIT (UROVYSION KIT) IS DESIGNED TO DETECT ANEUPLOIDY FOR CHROMOSOMES 3, 7, 17 AND LOSS OF THE 9P21 LOCUS VIA FLUORESCENCE IN SITU HYBRIDIZATION (FISH) IN URINE SPECIMENS FROM PERSONS WITH HEMATURIA SUSPECTED OF HAVING BLADDER CANCER. RESULTS FROM THE UROVYSION KIT ARE INTENDED FOR USE, IN CONJUNCTION WITH AND NOT IN LIEU OF CURRENT STANDARD DIAGNOSTIC PROCEDURES, AS AN AID FOR INITIAL DIAGNOSIS OF BLADDER CARCINOMA IN PATIENTS WITH HEMATURIA AND SUBSEQUENT MONITORING FOR TUMOR RECURRENCE IN PATIENTS PREVIOUSLY DIAGNOSED WITH BLADDER CANCER.