BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

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

    PMA: P140015 · Supplement: S010 · Decision Jul 20, 2016
    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 G4TM INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
    PMA Number
    P140015
    Supplement Number
    S010
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 20, 2016
    Date Received
    June 23, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Automate the software loading process performed during manufacture of the t:slim G4 Insulin Pump at the Tandem Diabetes Care manufacturing plant in San Diego, CA. The t:slim G4 Insulin Pump is a component of the Dexcom G4 Platinum CGM System. The proposed change does not alter the device design, materials, or performance specifications. The change does not affect the labeling of the device.

    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