BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P130007 · Supplement: S016 · Decision Dec 16, 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
    OneTouch Vibe™ Plus System
    PMA Number
    P130007
    Supplement Number
    S016
    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
    December 16, 2016
    Date Received
    June 6, 2016
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    16M-4458

    Advisory Committee Statement

    Approval for the OneTouch Vibe Plus System is indicated for continuous subcutaneous insulin infusion for the management of insulin-requiring diabetes. It can be used solely for continuous insulin delivery and as part of the OneTouch Vibe Plus System to receive and display continuous glucose measurements from the Dexcom G5® Sensor and Transmitter. The OneTouch Vibe Plus System's continuous glucose monitoring (CGM) is indicated for detecting trends and tracking patterns in persons (ages 2 and older) with diabetes, and is intended to complement, not replace, information obtained from standard home glucose monitoring devices. CGM 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 results from the Dexcom G5® Sensor and Transmitter should be based on the trends and patterns seen with several sequential readings over time. The System is intended for single patient use and requires a prescription.The Animas® Vibe® System’s continuous glucose monitoring (CGM) is indicated for detecting trends and tracking patterns in persons (age 2 and older) with diabetes, and is intended to complement, not replace, information obtained from standard home glucose monitoring devices. CGM 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 results from the Dexcom G5® Sensor and Transmitter should be based on the trends and patterns seen with several sequential readings over time.The 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