BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Processor, Cervical Cytology Slide, Automated

    PMA: P040052 · Decision Mar 3, 2006
    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
    Device Class
    FDA Class 3
    Product Code
    MKQ
    Generic Name
    Processor, cervical cytology slide, automated
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    March 3, 2006
    Date Received
    December 30, 2004
    Expedited Review
    N
    Docket Number
    06M-0264

    Advisory Committee Statement

    APPROVAL FOR THE MONOPREP PAP TEST (MPPT). THE DEVICE IS INTENDED FOR USE IN COLLECTING AND PREPARING CERVICAL-VAGINAL CYTOLOGY SPECIMENS FOR PAP STAIN-BASED SCREENING FOR CERVICAL CANCER, IT'S PRECURSOR LESIONS, AND OTHER CYTOLOGICAL CATEGORIES AND CONDITIONS DEFINED BY THE 2001 BETHESDA SYSTEM: TERMINOLOGY FOR REPORTING RESULTS OF CERVICAL CYTOLOGY. THE MONOPREP PAP TEST PRODUCES SLIDES THAT ARE INTENDED TO REPLACE CONVENTIONALLY PREPARED PAP SMEAR SLIDES.

    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