BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated Insulin Dosing , Threshold Suspend

    PMA: P120010 · Supplement: S046 · Decision Oct 2, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Automated Insulin Dosing , Threshold Suspend
    Trade Name
    MINIMED 530G INSULIN PUMP
    PMA Number
    P120010
    Supplement Number
    S046
    Device Class
    FDA Class 3
    Product Code
    OZO
    Generic Name
    Automated insulin dosing , threshold suspend
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 2, 2015
    Date Received
    December 10, 2014
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    15M-4013

    Advisory Committee Statement

    APPROVAL FOR THE MINIMED 530G SYSTEM WITH THRESHOLD SUSPEND FEATURING SMARTGUARD TECHNOLOGY. THIS DEVICE IS INDICATED FOR THE FOLLOWING:THE MINIMED 530G SYSTEM IS INTENDED FOR CONTINUOUS DELIVERY OF BASAL INSULIN (AT USER SELECTABLE RATES) AND ADMINISTRATION OF INSULIN BOLUSES (IN USER SELECTABLE AMOUNTS) FOR THE MANAGEMENT OF DIABETES MELLITUS IN PERSONS, SIXTEEN YEARS OF AGE AND OLDER, REQUIRING INSULIN AS WELL AS FOR THE CONTINUOUS MONITORING AND TRENDING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN. THE MINIMED 530G SYSTEM CAN BE PROGRAMMED TO AUTOMATICALLY SUSPEND DELIVERY OF INSULIN WHEN THE SENSOR GLUCOSE VALUE FALLS BELOW A PREDEFINED THRESHOLD VALUE. THE MINIMED 530G SYSTEM CONSISTS OF THE FOLLOWING DEVICES THAT CAN BE USED IN COMBINATION OR INDIVIDUALLY: MINIMED 530G INSULIN PUMP, ENLITE SENSOR, ENLITE SERTER, THE MINILINK REAL-TIME SYSTEM, THE BAYER CONTOUR NEXTLINK GLUCOSE METER, CARELINK PROFESSIONAL THERAPY MANAGEMENT SOFTWARE FOR DIABETES, AND CARELINK PERSONAL THERAPY MANAGEMENT SOFTWARE FOR DIABETES. THE SYSTEM REQUIRES A PRESCRIPTION.THE MINIMED 530G SYSTEM IS NOT INTENDED TO BE USED DIRECTLY FOR MAKING THERAPY ADJUSTMENTS, BUT RATHER TO PROVIDE AN INDICATION OF WHEN A FINGER STICK MAY BE REQUIRED. ALL THERAPY ADJUSTMENTS SHOULD BE BASED ON MEASUREMENTS OBTAINED USING A HOME GLUCOSE MONITOR AND NOT ON VALUES PROVIDED BY THE MINIMED 530G SYSTEM. THE MINIMED 530G SYSTEM IS NOT INTENDED TO BE USED DIRECTLY FOR PREVENTING OR TREATING HYPOGLYCEMIA BUT TO SUSPEND INSULIN DELIVERY WHEN THE USER IS UNABLE TO RESPOND TO THETHRESHOLD SUSPEND ALARM TO TAKE MEASURES TO PREVENT OR TREAT HYPOGLYCEMIA HIMSELF. THERAPY TO PREVENT OR TREAT HYPOGLYCEMIA SHOULD BE ADMINISTERED ACCORDING TO THERECOMMENDATIONS OF THE USER¿S HEALTH CARE PROVIDER.

    Classifications

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

    Product Code Device Name
    OZO Automated Insulin Dosing , Threshold Suspend