BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated Insulin Dosing , Threshold Suspend

    PMA: P120010 · Supplement: S001 · Decision Oct 2, 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
    S001
    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
    October 2, 2015
    Date Received
    November 6, 2013
    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 DUPLICATE EXISTING MANUFACTURING STEPS TO THE PREPARATION OF BULK GLUCOSE OXIDASE (GOX) PERFORMED BY THE SUPPLIER FOR USE IN THE SPONSOR¿S ENLITE SENSOR (MODEL: MMT-7008) AND SOF-SENSOR (MODELS: MMT-7002 AND MMT-7003) DEVICES. THE ENLITE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM. THE SOF-SENSOR IS A COMPONENT OF THE PARADIGM REAL-TIME, PARADIGM REALTIME REVEL, GUARDIAN REAL-TIME, MINILINK REAL-TIME, IPRO RECORDER AND IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEMS.

    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