BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated Insulin Dosing , Threshold Suspend

    PMA: P120010 · Decision Sep 26, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Automated Insulin Dosing , Threshold Suspend
    Trade Name
    MINIMED 530G SYSTEM
    PMA Number
    P120010
    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
    September 26, 2013
    Date Received
    June 5, 2012
    Expedited Review
    Y
    Docket Number
    13M-1206

    Advisory Committee Statement

    APPROVAL FOR THE MINIMED 5300 SYSTEM. THIS DEVICE IS INDICATED FOR THE FOLLOWING:MINIMED 530G SYSTEM - 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 THEMANAGEMENT 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. FOR ADDITIONAL INFORMATION PLEASE REFER TO APPROVAL ORDER.

    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