BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated Insulin Dosing , Threshold Suspend

    PMA: P180008 · Decision Jun 21, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Automated Insulin Dosing , Threshold Suspend
    Trade Name
    t:slim X2 Insulin Pump with Basal-IQ Technology
    PMA Number
    P180008
    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
    June 21, 2018
    Date Received
    February 26, 2018
    Expedited Review
    N
    Docket Number
    18M-2462

    Advisory Committee Statement

    Approval for the use of the t:slim X2 Insulin Pump with Basal-IQ Technology. This device is indicated as follows:The t:slim X2 Insulin Pump with Basal-IQ Technology (the System) consists of the t:slim X2 Insulin Pump which contains the Basal-IQ technology, and a continuous glucose monitor (CGM). Compatible CGMs include the Dexcom G5 Mobile CGM and integrated continuous glucose monitors (iCGMs) that are listed in the labeling for this device.The t:slim X2 Insulin Pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The t:slim X2 Insulin Pump can be used solely for continuous insulin delivery and as part of the t:slim X2 Insulin Pump with Basal-IQ Technology System.When the System is used with the Dexcom G5 Mobile CGM or a compatible iCGM, the Basal-IQ Technology can be used to suspend insulin delivery based on CGM sensor readings. The Dexcom G5 Mobile CGM Continuous Glucose Monitoring System (Dexcom G5) is indicated for the management of diabetes in persons age 2 years and older. The Dexcom G5 is designed to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the System results should be based on the trends and patterns seen with several sequential readings over time. The Dexcom G5 also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The Dexcom G5 is intended for single patient use and requires a prescription.The System is indicated for use in individuals 6 years of age and greater.The System is intended for single patient use and requires a prescription.The System is indicated for use with NovoLog or Humalog U-100 insulin.

    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