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

    Automated Insulin Dosing , Threshold Suspend

    PMA: P150001 · Supplement: S007 · Decision Jan 11, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Automated Insulin Dosing , Threshold Suspend
    Trade Name
    MINIMED 630G SYSTEM WITH SMARTGUARD
    PMA Number
    P150001
    Supplement Number
    S007
    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
    January 11, 2017
    Date Received
    December 12, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    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 630G System and the iPro2 CGM 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