BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S110 · Decision Jul 17, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM
    PMA Number
    P980022
    Supplement Number
    S110
    Device Class
    FDA Class 3
    Product Code
    MDS
    Generic Name
    Sensor, glucose, invasive
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 17, 2012
    Date Received
    February 9, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LANGUAGE AND PICTORIAL CHANGES TO THE INSTRUCTIONS FORUSE (IFU) OF THE SOF-SENSOR GLUCOSE SENSOR (MMT-7002) TO MAKE IT CONSISTENT WITH THE LANGUAGE THAT IS INCLUDED IN THE CURRENTLY APPROVED PARADIGM REAL-TIME REVEL INSULIN PUMP AND PARADIGM REAL-TIME INSULIN PUMP USER GUIDES. THE SOF-SENSOR, PARADIGM REAL-TIME REVEL INSULIN PUMP AND PARADIGM REAL-TIME INSULIN PUMP ARE COMPONENTS OF THE PARADIGM REAL- TIME SYSTEM, GUARDIAN REAL-TIME SYSTEM, AND IPRO2 PROFESSIONAL CONTINUOUS GLUCOSEMONITORING (CGM) SYSTEM.

    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