BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Processor, Cervical Cytology Slide, Automated

    PMA: P040052 · Supplement: S006 · Decision Jul 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Processor, Cervical Cytology Slide, Automated
    Trade Name
    MONOPREP PAP TEST
    PMA Number
    P040052
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    MKQ
    Generic Name
    Processor, cervical cytology slide, automated
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 9, 2008
    Date Received
    January 18, 2008
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES BASED ON THE ANALYSIS OF DATA FROM THE POST-MARKET STUDY ENTITLED SURE (SPECIMEN UNSAT RATE EVALUATION). THESE CHANGES HAVE BEEN INCORPORATED INTO THE LABORATORY INFORMATION AND INSTRUCTIONS LABELING.

    Classifications

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

    Product Code Device Name
    MKQ Processor, Cervical Cytology Slide, Automated