BEUDAMED
    FDA PMA FDA Class 3 🇺🇸 United States

    Reader, Cervical Cytology Slide, Automated

    PMA: P020002 · Decision Jun 6, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Reader, Cervical Cytology Slide, Automated
    Trade Name
    THINPREP (R) IMAGING SYSTEM
    PMA Number
    P020002
    Device Class
    FDA Class 3
    Product Code
    MNM
    Generic Name
    READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision Code
    APCB
    Decision Date
    June 6, 2003
    Date Received
    January 7, 2002
    Expedited Review
    N
    Docket Number
    03M-0339

    Advisory Committee Statement

    APPROVAL FOR THE THINPREP IMAGING SYSTEM. THE DEVICE IS INDICATED FOR ASSISTING IN PRIMARY CERVICAL CANCER SCREENING OF THINPREP PAP TEST SLIDES FOR THE PRESENCE OF ATYPICAL CELLS, CERVICAL NEOPLASIA, INCLUDING ITS PRECURSOR LESIONS (LOW GRADE SQUAMOUS INTRAEPITHELIAL LESIONS, HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESIONS, AND CARCINOMA AS WELL AS ALL OTHER CYTOLOGICAL CRITERIA AS DEFINED BY THE 2001 BETHESDA SYSTEM: TERMINOLOGY FOR REPORTING RESULTS OF CERVICAL CYTOLOGY.

    Classifications

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

    Product Code Device Name
    MNM Reader, Cervical Cytology Slide, Automated