BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Processor, Cervical Cytology Slide, Automated

    PMA: P950039 · Supplement: S016 · Decision Jan 18, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Processor, Cervical Cytology Slide, Automated
    Trade Name
    THINPREP 2000 SYSTEM
    PMA Number
    P950039
    Supplement Number
    S016
    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
    January 18, 2006
    Date Received
    July 22, 2005
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDITIONAL CLAIMS TO THE CURRENT LABELING. THE ADDITIONAL CLAIMS CONSIST OF EXTENSION OF THE EXPIRATION DATE OF THE PRESERVCYT SAMPLE VIALS TO SIX WEEKS, REPROCESSING "UNSATISFACTORY FOR EVALUATION" SLIDES WITH A CYTOLYT SOLUTION AND GLACIAL ACETIC ACID WASH, AND REFERENCE TO THE GEN-PROBE APTIMA ASSAYS FOR THE DETECTION OF CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE.

    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