BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S115 · Decision Apr 26, 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) AND CGMS IPRO RECORDER (MMT-7709)
    PMA Number
    P980022
    Supplement Number
    S115
    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
    April 26, 2012
    Date Received
    March 8, 2012
    Supplement Type
    Real-Time Process
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE FROM A SINGLE CAVITY INJECTION MOLD TO A TWO CAVITYINJECTION MOLD FOR THE MANUFACTURE OF THE CONNECTOR HOUSING AND CONTACT COMPONENTS OF THE MINILINK TRANSMITTER (MMT-7703) AND IPRO DIGITAL RECORDER (MMT-7709). THE MINILINK TRANSMITTER AND IPRO DIGITAL RECORDER ARE COMPONENTS OF PARADIGM REAL-TIME, GUARDIANREAL-TIME AND IPRO 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