BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Reader, Cervical Cytology Slide, Automated

    PMA: P020002 · Supplement: S002 · Decision Apr 28, 2006
    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
    S002
    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
    April 28, 2006
    Date Received
    March 30, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR SOFTWARE AND LABELING MODIFICATIONS OF THE THINPREP IMAGING SYSTEM FOR REMOTE REVIEWING CAPABILITY & LABELING CHANGE FOR THE THINPREP IMAGING SYSTEM TO INCORPORATE A NEW LIMITATION FOR SPECIMEN REPROCESSING.

    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