BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P050020 · Supplement: S017 · Decision Jan 19, 2010
    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
    S017
    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
    January 19, 2010
    Date Received
    June 17, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A PROCESS VALIDATION ON THE SHARP MANUFACTURED AT OBERG INDUSTRIES (IN FREEPORT, PENNSYLVANIA) AS WELL AS TO WIDEN DIMENSIONAL TOLERANCES ON THE SHARP IN BOTH LENGTH AND ANGLE BEND. CURRENTLY ALL SHARPS PRODUCED AT OBERG MUST UNDERGO 100% INSPECTION AT FACET (IN MARIETTA, GEORGA) PRIOR TO ITS ASSEMBLING INTO THE SENSOR INSERTER OF THE SENSOR DELIVERY UNIT (SDU) OF THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM. THE PROCESS VALIDATION PROVIDED IN THIS SUPPLEMENT WILL REPLACE THE 100% INSPECTION REQUIREMENT AT FACET.

    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