BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P140015 · Decision Sep 8, 2015
    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
    PMA Number
    P140015
    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
    September 8, 2015
    Date Received
    July 17, 2014
    Expedited Review
    N
    Docket Number
    15M-3376

    Advisory Committee Statement

    APPROVAL FOR THE T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (¿T:SLIM G4 SYSTEM¿). THIS DEVICE CONSISTS OF THE T:SLIM G4 INSULIN PUMP PAIRED WITH THE DEXCOM G4 PLATINUM SENSOR AND TRANSMITTER.THE T:SLIM G4 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 G4 INSULIN PUMP CAN BE USED SOLELY FOR CONTINUOUS INSULIN DELIVERY AND AS PART OF THE T:SLIM G4 SYSTEM TO RECEIVE AND DISPLAY CONTINUOUS GLUCOSE MEASUREMENTS FROM THE DEXCOM G4 PLATINUM SENSOR AND TRANSMITTER. THE T:SLIM G4 SYSTEM ALSO INCLUDES CONTINUOUS GLUCOSE MONITORING (CGM) INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS WITH DIABETES FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE T:SLIM G4 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 G4 SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME. THE T:SLIM G4 SYSTEM IS INDICATED FOR USE IN INDIVIDUALS 12 YEARS OF AGE AND GREATER. THE T:SLIM G4 SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION.

    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