BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated Insulin Dosing , Threshold Suspend

    PMA: P120010 · Supplement: S091 · Decision Dec 8, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Automated Insulin Dosing , Threshold Suspend
    Trade Name
    Artificial Pancreas Device System, Threshold Suspend
    PMA Number
    P120010
    Supplement Number
    S091
    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
    December 8, 2016
    Date Received
    June 15, 2016
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for adding a Cell Operating System (COS) for partial manual assembly of Enlite Sensors at Medtronic Puerto Rico Operations Company (MPROC) facility. The implementation of a COS includes adding new equipment and relocating existing equipment within the existing Enlite sensor manual assembly line. The Enlite sensor is a component of the MiniMed 530G System and the Paradigm Real-Time Revel System with Enlite Sensor.

    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