BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S123 · Decision Oct 26, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    GUARDIAN REAL-TIME MONITOR, MODEL CSS7100. CS7100K
    PMA Number
    P980022
    Supplement Number
    S123
    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
    October 26, 2012
    Date Received
    August 30, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MINOR SOFTWARE MODIFICATIONS IN GUARDIAN® REAL-TIME SYSTEM TO OPTIMIZE THE SHUTDOWN PROCEDURE FOR THE GUARDIAN MONITOR AND TO CORRECT AN ANOMALY THAT ALLOWED ACCESS OF OUT-OF-BOUNDS POINTER ERRORS.

    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