BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Analyzer, Diagnostic, Fiber Optic (Colon)

    PMA: P990050 · Supplement: S006 · Decision Mar 28, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Analyzer, Diagnostic, Fiber Optic (Colon)
    Trade Name
    WAVSTAT OPTICAL BIOPSY SYSTEM
    PMA Number
    P990050
    Supplement Number
    S006
    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
    March 28, 2006
    Date Received
    July 19, 2005
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT SPECTRASCIENCE, INC., SAN DIEGO, CALIFORNIA.

    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)