BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Processor, Cervical Cytology Slide, Automated

    PMA: P950039 · Supplement: S015 · Decision Sep 28, 2005
    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
    S015
    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
    September 28, 2005
    Date Received
    April 1, 2005
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDITIONAL CLAIMS TO THE CURRENT APPROVED LABELING FOR THINPREP 2000 SYSTEM REGARDING REMOVAL OF A 4 ML ALIQUOT FROM THE PRESERVCYT VIAL PRIOR TO PREPARATION OF THE THINPREP PAP TEST(TPPT). THIS ALIQUOT IS ONLY TO BE USED TO SUPPORT PERFORMANCE OF ANCILLARY TESTS APPROVED BY THE FDA ON PRESERVCYT MATERIAL.

    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