BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

    PMA: P030052 · Supplement: S017 · Decision Dec 29, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence
    Trade Name
    UROVYSION BLADDER CANCER KIT,PROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT
    PMA Number
    P030052
    Supplement Number
    S017
    Device Class
    FDA Class 3
    Product Code
    NSD
    Generic Name
    Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 29, 2015
    Date Received
    November 12, 2015
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MANUFACTURING PROCESS CHANGES TO COMPONENTS OF THEPROBECHEK CONTROL SLIDES FOR FISH USING UROVYSION BLADDER CANCER KIT.

    Classifications

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

    Product Code Device Name
    NSD Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence