BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P050012 · Supplement: S021 · Decision Dec 4, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    DEXCON SEVEN SENSOR
    PMA Number
    P050012
    Supplement Number
    S021
    Device Class
    FDA Class 3
    Product Code
    MDS
    Generic Name
    Sensor, glucose, invasive
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 4, 2009
    Date Received
    November 5, 2009
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    REPLACEMENT OF PAPER-BASED LOT HISTORY RECORDS (LHRS) WITH ELECTRONIC LHRS. THE CHANGE IMPLEMENTS CAMSTAR MANUFACTURING EXECUTION SYSTEM (MES), AN ELECTRONIC CONTROL SYSTEM FOR MANAGING AND MONITORING WORK-IN PROCESS ON A MANUFACTURING FLOOR.

    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