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

    Sensor, Glucose, Invasive

    PMA: P160007 · Supplement: S037 · Decision Sep 2, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    Guardian Connect System
    PMA Number
    P160007
    Supplement Number
    S037
    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
    September 2, 2020
    Date Received
    August 4, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    IntriCon Corporation (IntriCon Red Fox), 1260 Red Fox Road, Saint Paul, MN as an alternative finished product manufacturing facility and IntriCon Corporation Grey Fox (IntriCon Grey Fox), 1275 Grey Fox Road Arden Hills, MN as an alternate final packaging process facility for the Guardian Link (3) and Guardian Connect Transmitter. The transmitters are components of the MiniMed 630G System with SmartGuard, Guardian Connect System, and MiniMed 670G System. The submission also requested approval of process changes related to the new manufacturing facilities including a new inspection process and equipment.

    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