BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S166 · Decision May 13, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    SOF-SENSOR
    PMA Number
    P980022
    Supplement Number
    S166
    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
    May 13, 2015
    Date Received
    October 30, 2014
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE CALCULATION METHOD USED TO DETERMINE THE AMOUNT OF PLATINUM TO ADD IN THE MANUFACTURE OF THE PLATINUM SOLUTION USED IN THE FABRICATION PROCESS FOR THE SOF-SENSOR AND ENLITE SENSORS, AND FOR THE ENLITE SENSOR ONLY, THE ADDITION OF EQUIPMENT USED TO VERIFY THE PLATINUM SOLUTION CONCENTRATION.

    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