BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S061 · Decision Nov 5, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    SOF-SENSOR GLUCOSE SENSORS
    PMA Number
    P980022
    Supplement Number
    S061
    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
    November 5, 2009
    Date Received
    September 29, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE REPLACEMENT OF THE CURRENT SOF-SENSOR GLUCOSE SENSOR MMT-7002 AND MMT-7003 POUCH WITH A SIMILAR ONE BY SUPPLIER TOLAS HEALTHCARE. THE DIFFERENCE BETWEEN THE TWO POUCHES IS THAT THE BOTTOM WEB OF THE POUCH IS CHANGED FROM P/N TPF-0521 TO P/N TPF-0521 NC DUE TO THE CHANGE OF THE SUPPLIER FOR TOLAS HEALTHCARE.

    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