BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P050020 · Supplement: S003 · Decision May 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    FREESTYLE NAVIGATOR
    PMA Number
    P050020
    Supplement Number
    S003
    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 21, 2008
    Date Received
    April 21, 2008
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR TWO LABELING MODIFICATIONS: 1) TO MODIFY A WARNING REGARDING USE OF THE SYSTEM IN AN ENVIRONMENT WHERE ANESTHETIC GAS IS USED TO INSTEAD WARN AGAINST USE IN ENVIRONMENTS THAT CONTAIN ANY COMBUSTIBLE GAS; AND 2) TO ADD LANGUAGE TO THE INSTRUCTIONS FOR MUTING ALARMS TO CLARIFY WHEN IT IS NOT RECOMMENDED TO DO SO AND ALSO TO CLARIFY WHEN THE SYSTEM WILL GO INTO ABANDON ALARM MODE WHEN THE ALARMS ARE MUTED.

    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