BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Analyzer, Diagnostic, Fiber Optic (Colon)

    PMA: P990050 · Supplement: S003 · Decision Nov 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Analyzer, Diagnostic, Fiber Optic (Colon)
    Trade Name
    WAVSTAT (TM) OPTICAL BIOPSY SYSTEM
    PMA Number
    P990050
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    MOA
    Generic Name
    ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 28, 2001
    Date Received
    September 17, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW CONSOLE TO BE USED WITH THE OBS. THIS NEW CONSOLE CONSISTS OF A RECONFIGURATINO OF THE ORIGINAL CONSOLE AND INCORPORATES SEVERAL FEATURES INTENDED TO IMPROVE USABILITY OF THE DEVICE.

    Classifications

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

    Product Code Device Name
    MOA Analyzer, Diagnostic, Fiber Optic (Colon)