BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S100 · Decision Jul 6, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    MINILINK TRANSMITTER (MMT-7703), IPRO DIGITAL RECORDER (MMT-7709) AND IPRO2 RECORDER (MMT-7741)
    PMA Number
    P980022
    Supplement Number
    S100
    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 6, 2012
    Date Received
    October 28, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN INCREASE IN BATTERY LEAD WIRE LENGTH AND TOLERANCES, AND INCREASE WIRE STRIPPING TOLERANCES TO MATCH WITH THE WIRE STRIP TOOL CAPABILITIES AFFECTING THE MINILINK TRANSMITTER (MMT-7703), CGMS IPRO RECORDER (MMT-7709) AND IPRO2 RECORDER (MMT-7741), WHICH ARE COMPONENTS OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, IPRO 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
    MDS Sensor, Glucose, Invasive