BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980022 · Supplement: S006 · Decision Jan 9, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CONTINUOUS GLUCOSE MONITORING SYSTEM
    PMA Number
    P980022
    Supplement Number
    S006
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 9, 2001
    Date Received
    September 21, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW MANUFACTURING SITE FOR THE MANUFACTURER OF THE EXTERNAL COMPONENTS OF THE DEVICE. THE NEW SITE IS MINIMED, INC., NORTHRIDGE, CALIFORNIA.