BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated Insulin Dosing , Threshold Suspend

    PMA: P120010 · Supplement: S041 · Decision Jan 28, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Automated Insulin Dosing , Threshold Suspend
    Trade Name
    ENLITE GLUCOSE SENSORS
    PMA Number
    P120010
    Supplement Number
    S041
    Device Class
    FDA Class 3
    Product Code
    OZO
    Generic Name
    Automated insulin dosing , threshold suspend
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 28, 2015
    Date Received
    October 30, 2014
    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 SENSOR BASE, O-RING, TAPE, ADHESIVE AND SENSOR PATCH OF THE ENLITE GLUCOSE SENSOR (MMT-7008A, MMT-7008B) IN ORDER TO SUPPORT MANUFACTURING CHANGES FROM A MANUAL ASSEMBLY PROCESS TO AN AUTOMATED ASSEMBLY LINE FOR THE ENLITE GLUCOSE SENSOR. THE ENLITE GLUCOSE SENSOR IS A COMPONENT OF THE MINIMED 530GSYSTEM.

    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