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

    Automated Insulin Dosing , Threshold Suspend

    PMA: P120010 · Supplement: S011 · Decision Mar 20, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Automated Insulin Dosing , Threshold Suspend
    Trade Name
    ENLITE GLUCOSE SENSOR
    PMA Number
    P120010
    Supplement Number
    S011
    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
    March 20, 2014
    Date Received
    February 18, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE MANUFACTURING PROCESS FOR THE ENLITETM GLUCOSE SENSOR (MODEL NUMBERS: MMT-7008A, MMT-7008B) TO ADD A NEW SENSOR FABRICATION CONFIGURATION TO INCLUDE A 48-UP SENSOR MASK WHICH WILL BE MANUFACTURED BY A NEW VENDOR. THE ENLITETM GLUCOSE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.

    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