BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated Insulin Dosing , Threshold Suspend

    PMA: P120010 · Supplement: S030 · Decision Feb 4, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Automated Insulin Dosing , Threshold Suspend
    Trade Name
    ENLITE SENSOR
    PMA Number
    P120010
    Supplement Number
    S030
    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
    February 4, 2015
    Date Received
    July 7, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE SENSOR BASE WHICH INCLUDED; THE ADDITION OF ANTI-ROTATION PINS AND SNAP ARMS, MODIFICATION OF THE O-RING GLAND; WIDTH, POSITION, AND DIAMETER, AN INCREASE TO THE BORE SIZE AND ADDITION OF A BORE TAPER, A SENSOR THROUGH-HOLE SIZE INCREASE, AND CONNECTOR PAD SURFACE HEIGHT INCREASE, ON THE ENLITETM GLUCOSE SENSOR (MMT-7008) 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