BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P130007 · Supplement: S004 · Decision Dec 24, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    ANIMAS VIBE SYSTEM
    PMA Number
    P130007
    Supplement Number
    S004
    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
    December 24, 2015
    Date Received
    April 30, 2015
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    16M-0120

    Advisory Committee Statement

    APPROVAL FOR THE ANIMAS VIBE SYSTEM. THE ANIMAS® VIBE SYSTEM CONSISTS OF THE ANIMAS VIBE INSULIN PUMP PAIRED WITH THE DEXCOM G4 PLATINUM CGM SENSOR AND TRANSMITTER.THE ANIMAS VIBE INSULIN PUMP IS INTENDED FOR THE CONTINUOUS SUBCUTANEOUS INFUSION OF INSULIN FOR THE MANAGEMENT OF INSULIN-REQUIRING DIABETES. IT CAN BE USED SOLELY FOR CONTINUOUS INSULIN DELIVERY OR AS PART OF THE ANIMAS VIBE SYSTEM TO RECEIVE AND DISPLAY CONTINUOUS GLUCOSE MEASUREMENTS FROM THE DEXCOM G4 PLATINUM SENSOR AND TRANSMITTER. THE ANIMAS VIBE SYSTEMS CONTINUOUS GLUCOSE MONITORING (CGM) IS INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS (AGE 2 AND OLDER) WITH DIABETES, AND IS INTENDED TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. CGM 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 RESULTS FROM THE DEXCOM G4 PLATINUM SENSOR AND TRANSMITTER SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.THE ANIMAS VIBE SYSTEM IS INTENDED FOR SINGLE PATIENT USE IN PERSONS AGE 2 AND OLDER AND REQUIRES A PRESCRIPTION.

    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