BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P050020 · Supplement: S010 · Decision Sep 25, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
    PMA Number
    P050020
    Supplement Number
    S010
    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
    September 25, 2009
    Date Received
    February 2, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL NEW PACKAGING AND DESICCANT FOR THE INSERTER SUBCOMPONENT OF THE SENSOR DELIVERY UNIT (SDU), WHICH IS A COMPONENT OF THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM. THIS MODIFICATION TO THE ORIGINAL APPROVED DEVICE RESULTS IN A NEWSTERILIZATION CONFIGURATION, A NEW PACKAGE AND NEW STERILIZATION METHOD (EO) FOR THE SENSORSUPPORT MOUNT SUBCOMPONENT OF THE SDU, USER ASSEMBLY OF THE INSERTER WITH THE SENSOR SUPPORTMOUNT SECTION, NEW SECONDARY CONTAINERS FOR THE SUBCOMPONENTS OF THE SDU SECTION, AND CHANGES TO SDU LABELING CORRESPONDING TO THE PACKAGING CHANGES.

    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