BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Analyzer, Diagnostic, Fiber Optic (Colon)

    PMA: P990050 · Supplement: S002 · Decision Aug 17, 2001
    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 SYTEM
    PMA Number
    P990050
    Supplement Number
    S002
    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
    August 17, 2001
    Date Received
    July 20, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE TRADE NAME OF THE DEVICE AND RELATED ACCESSORIES TO ADD THE WORD "WAVSTAT(TM)" TO THE BEGINNING OF THE TRADE NAME. THE DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO LOWER GASTROINTESTINAL (GI) ENDOSCOPY. THE DEVICE IS INTENDED FOR THE EVALUATION OF POLYPS LESS THAN 1 CM IN DIAMETER THAT THE PHYSICIAN HAS NOT ALREADY ELECTED TO REMOVE. THE DEVICE IS ONLY TO BE USED IN DECIDING WHETHER SUCH POLYPS SHOULD BE REMOVED (WHICH INCLUDES SUBMISSION FOR HISTOLOGICAL EXAMINATION).

    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)