BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

    PMA: P140015 · Supplement: S020 · Decision Aug 25, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
    Trade Name
    t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM
    PMA Number
    P140015
    Supplement Number
    S020
    Device Class
    FDA Class 3
    Product Code
    OYC
    Generic Name
    Pump, infusion, insulin, to be used with invasive glucose sensor
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 25, 2017
    Date Received
    March 1, 2017
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    17M-5262

    Advisory Committee Statement

    Approval for the use of the t:slim X2 Insulin Pump with the Dexcom G5 Mobile CGM and for modifying the indications for use to include pediatric patients ages 6-11 years and replace adjunctive with non-adjunctive CGM use (i.e., replace fingerstick blood glucose testing for diabetes treatment decisions). This device is indicated as follows:The t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM (“t:slim X2 System”) consists of the t:slim X2 Insulin Pump paired with the Dexcom G5 Mobile Sensor and Transmitter. 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 System to receive and display continuous glucose measurements from the Dexcom G5 Mobile Sensor and Transmitter. The t:slim X2 System also includes continuous glucose monitoring (CGM) indicated for the management of diabetes. The Dexcom G5 Mobile CGM is designed to replace fingerstick blood glucose testing for diabetes treatment decisions. The t:slim X2 System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the t:slim X2 System results should be based on the trends and patterns seen with several sequential readings over time. The t:slim X2 System is indicated for use in individuals 6 years of age and greater. The t:slim X2 System is intended for single patient use and requires a prescription. The device 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
    OYC Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor