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

    Sensor, Glucose, Invasive

    PMA: P140015 · Supplement: S005 · Decision Oct 15, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    TSLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM
    PMA Number
    P140015
    Supplement Number
    S005
    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
    October 15, 2015
    Date Received
    September 18, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    REMOVAL OF A NON-DESTRUCTIVE TEST AND A MOVE OF AN EXISTING DESTRUCTIVE TEST TO AN EARLIER POINT IN THE MANUFACTURING PROCESS OF THE T:SLIM INSULIN CARTRIDGE. THE INSULIN CARTRIDGE IS A DISPOSABLE COMPONENT OF THE T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM.

    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