BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Processor, Cervical Cytology Slide, Automated

    PMA: P950039 · Supplement: S009 · Decision Feb 5, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Processor, Cervical Cytology Slide, Automated
    Trade Name
    PRESERVCYT SOLUTION ALTERNATIVE TRANSPORT MEDIUM
    PMA Number
    P950039
    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 5, 2003
    Date Received
    January 21, 2003
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES TO THE PACKAGE INSERT: 1) THE ADDITION OF A CONTRAINDICATION FOR THOSE SAMPLES PROCESSED USING THE THINPREP 3000 PROCESSING SYSTEM. 2) THE ADDITION OF A PRECAUTION TO ADDRESS THE ALTERNATIVE SPECIMEN PROCESSING METHODS USING THE THINPREP 2000 PROCESSING SYSTEM FOR THOSE SAMPLES THAT WILL BE TESTED FOR CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE USING THE ROCHE DIAGNOSTICS COBAS AMPLICOR CT/NG TEST. 3) THE ADDITION OF THE ALTERNATIVE SPECIMEN HANDLING METHOD TO TABLE 1 OF THE PACKAGE INSERT.

    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