BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Reader, Cervical Cytology Slide, Automated

    PMA: P020002 · Supplement: S010 · Decision Jun 2, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Reader, Cervical Cytology Slide, Automated
    Trade Name
    THINPREP IMAGING SYSTEM
    PMA Number
    P020002
    Supplement Number
    S010
    Device Class
    FDA Class 3
    Product Code
    MNM
    Generic Name
    READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 2, 2015
    Date Received
    November 14, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR USE OF THE THINPREP IMAGING SYSTEM WITH THE SLIDES PREPARED BY THE THINPREP 5000 SLIDE PROCESSOR.

    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