BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P050020 · Supplement: S013 · Decision Apr 9, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    FREESTYLE NAVIGATOR CONTIUOUS GLUCOSE MONITORING SYSTEM
    PMA Number
    P050020
    Supplement Number
    S013
    Device Class
    FDA Class 3
    Product Code
    MDS
    Generic Name
    Sensor, glucose, invasive
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 9, 2009
    Date Received
    March 20, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN UPDATED VERSION OF THE COPILOT HEALTH MANAGEMENT SYSTEM FOR FREESTYLE NAVIGATOR LABELING AND HELP FILES IN THE APPLICATION TO ADD WINDOWS VISTA AS AN OPERATING SYSTEM THAT THE APPLICATION CAN BE INSTALLED ON AS WELL AS ADDING THE NECESSARY STEPS TO ALLOW THE APPLICATION AND DEVICE TO BE USED WITH VISTA.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MDS Sensor, Glucose, Invasive