BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P120005 · Supplement: S011 · Decision Jun 3, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM
    PMA Number
    P120005
    Supplement Number
    S011
    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
    June 3, 2014
    Date Received
    September 16, 2013
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM, THAT INCLUDES THE DEXCOM G4 PLATINUM PROFESSIONAL RECEIVER SHIELD, TO ALLOW MULTIPLE PATIENT USE OF THE SYSTEM BY A HEALTHCARE PROFESSIONAL. THE DEVICE, AS MODIFIED, WILL BE MARKETEDUNDER THE TRADE NAME G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM AND IS INDICATED FOR:THE DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM IS A GLUCOSE MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS (AGE 18 AND OLDER) WITH DIABETES. THE SYSTEM IS INTENDED FOR MULTIPLE PATIENT USE AND REQUIRES PURCHASE BY A HEALTHCARE PROVIDER. THE SYSTEM IS NOT INTENDED FOR USE IN A HOSPITAL SETTING.THE DEXCOM G4 PLATINUM PROFESSIONAL SYSTEM IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES.THE DEXCOM G4 PLATINUM PROFESSIONAL SYSTEM AIDS IN THE DETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS. INTERPRETATION OF THE G4 PLATINUM PROFESSIONAL SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERALSEQUENTIAL READINGS OVER TIME.

    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