BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P050020 · Supplement: S002 · Decision May 15, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
    PMA Number
    P050020
    Supplement Number
    S002
    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
    May 15, 2008
    Date Received
    April 2, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) THE ADDITION OF A CARBON COATING TO THE BACK OF THE SENSOR TAIL TO IMPROVE ADHESION OF THE MEMBRANE IN ORDER TO ELIMINATE MICROSCOPIC MEMBRANE FRAGMENTATION; 2) A CHANGE IN THE ORIENTATION OF THE POSITION OF THE SENSOR DURING THE MANUFACTURING PROCESS TO FACILITATE INSPECTION; 3) A LABELING CHANGE, RESULTING FROM THE BACKSIDE CARBON COATING, TO ELIMINATE A CAUTION REGARDING MEMBRANE FRAGMENTS REMAINING IN THE SKIN; 4) AND A CHANGE IN A SUB-SUPPLIER MANUFACTURING SITE, DUPONT, HOPEWELL, VIRGINIA.

    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