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

    Sensor, Glucose, Invasive

    PMA: P150029 · Supplement: S005 · Decision Jan 11, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    IPRO2 CGM SYSTEM WITH ENLITE SENSOR
    PMA Number
    P150029
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    MDS
    Generic Name
    Sensor, glucose, invasive
    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
    MDS Sensor, Glucose, Invasive