BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Reader, Cervical Cytology Slide, Automated

    PMA: P950009 · Supplement: S021 · Decision Jun 17, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Reader, Cervical Cytology Slide, Automated
    Trade Name
    BD FOCALPOINT GS IMAGING SYSTEM
    PMA Number
    P950009
    Supplement Number
    S021
    Device Class
    FDA Class 3
    Product Code
    MNM
    Generic Name
    READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 17, 2016
    Date Received
    May 19, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Changes to the printed circuit board reported in this supplement in conjunction with the changes to replace VIC chip and change of manufacturing supplier qualify.

    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