BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Processor, Cervical Cytology Slide, Automated

    PMA: P970018 · Supplement: S009 · Decision Feb 11, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Processor, Cervical Cytology Slide, Automated
    Trade Name
    PREPSTAIN SYSTEM
    PMA Number
    P970018
    Supplement Number
    S009
    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 11, 2005
    Date Received
    January 10, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATION TO THE SUREPATH SLIDE PREPARATION METHOD WHICH WILL BE MARKETED UNDER THE TRADE NAME PREPSTAIN SYSTEM AND IS INDICATED FOR USE AS A LIQUID-BASED THIN LAYER CELL PREPARATION PROCESS. THE PRESTAIN SYSTEM PRODUCES SUREPATH SLIDES THAT ARE INTENDED AS REPLACEMENTS FOR CONVENTIONAL GYNECOLOGIC PAP SMEARS. SUREPATH SLIDES ARE INTENDED FOR USE IN THE SCREENING AND DETECTION OF CERVICAL CANCER, PRE-CANCEROUS LESIONS, ATYPICAL CELLS AND ALL OTHER CYTOLOGIC CATEGORIES AS DEFINED BY THE BETHESDA SYSTEM FOR REPORTING CERVICAL/VAGINAL CYTOLOGIC DIAGNOSES.

    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