BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Processor, Cervical Cytology Slide, Automated

    PMA: P950039 · Supplement: S002 · Decision Feb 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Processor, Cervical Cytology Slide, Automated
    Trade Name
    THINPREP(R) 2000 SYSTEM
    PMA Number
    P950039
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    MKQ
    Generic Name
    Processor, cervical cytology slide, automated
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 25, 1997
    Date Received
    July 30, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Other
    Expedited Review
    N
    Docket Number
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF THE COMBINATION OF ENDOCERVICAL BRUSH AND PLASTIC SPATULA AS AN ALTERNATIVE TOT HE BROOM-TYPE SAMPLING DEVICE FOR THE THINPREP 2000 SYSTEM

    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