BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P140015 · Supplement: S024 · Decision Apr 17, 2018
    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 G4 Insulin Pump with Dexcom G4 Platinum CGM (t:slim G4 system); t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM
    PMA Number
    P140015
    Supplement Number
    S024
    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
    April 17, 2018
    Date Received
    January 17, 2018
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for minor design changes to the pump housing and patient line port of the t:slim X2 Insulin Pump. The t:slim X2 Insulin Pump is a part of the t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System.

    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