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

    Automated Insulin Dosing , Threshold Suspend

    PMA: P180008 · Supplement: S006 · Decision Oct 26, 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
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    OZO
    Generic Name
    Automated insulin dosing , threshold suspend
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 26, 2018
    Date Received
    September 27, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change the procedure for wake button replacement during PCBA refurbishment by discontinuing replacement of the wake button if it meets specific criteria and by transferring various reprogramming steps in-house. The wake button switch assemblies are components of the t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM and the t:slim Insulin Pump with Basal-IQ Technology.

    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