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: S001 · Decision May 10, 2006
    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
    PMA Number
    P030052
    Supplement Number
    S001
    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
    May 10, 2006
    Date Received
    June 20, 2005
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT DES PLAINES, DES PLAINES, ILLINOIS.

    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