BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

    PMA: P130007 · Decision Nov 25, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
    Trade Name
    ANIMAS VIBE SYSTEM
    PMA Number
    P130007
    Device Class
    FDA Class 3
    Product Code
    OYC
    Generic Name
    Pump, infusion, insulin, to be used with invasive glucose sensor
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    November 25, 2014
    Date Received
    April 17, 2013
    Expedited Review
    N
    Docket Number
    14M-2246

    Advisory Committee Statement

    APPROVAL FOR THE ANIMAS VIBE SYSTEM. THIS DEVICE IS INDICATED FOR:THE ANIMAS® VIBE¿ SYSTEM CONSISTS OF THE ANIMAS® VIBE¿ INSULIN PUMP PAIRED WITH THE DEXCOM G4 PLATINUM SENSOR AND TRANSMITTER.THE ANIMAS® VIBE¿ INSULIN PUMP IS INDICATED FOR CONTINUOUS SUBCUTANEOUS INSULIN INFUSION FOR THE MANAGEMENT OF INSULIN-REQUIRING DIABETES. IT CAN BE USED SOLELY FOR CONTINUOUS INSULIN DELIVERY AND 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¿ SYSTEM'S CONTINUOUS GLUCOSE MONITORING (CGM) IS INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS (AGE 18 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 SYSTEM IS INTENDED FOR SINGLE PATIENT USE 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
    OYC Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor