BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P120005 · Supplement: S013 · Decision Feb 26, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    DEXCOM G4 PLATINUM CONTINOUS GLUCOSE MONITORING SYSTEM
    PMA Number
    P120005
    Supplement Number
    S013
    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
    February 26, 2014
    Date Received
    September 30, 2013
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR END OF LIFE COMPONENT CHANGES (SPEAKER DRIVER-CODEC, FLASH, MOSFET, SDRAM, CAPACITOR (CAP), AND RF CHIP) IN THE RECEIVER PRINTED CIRCUIT BOARD ASSEMBLY, USE OF A HIGHER CAPACITY CAPACITOR AND IMPROVEMENT IN THE METHOD OF ATTACHMENT OF A USB PORT CONNECTOR IN THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING 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