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

    Sensor, Glucose, Invasive

    PMA: P130007 · Supplement: S007 · Decision Aug 18, 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
    S007
    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
    August 18, 2015
    Date Received
    July 21, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO THE CURRENT BASE ASSEMBLY PROCESS USED FOR THE MANUFACTURE OF THEPUMP BASE OF THE ANIMAS VIBE SYSTEM TO IMPROVE OVERALL MANUFACTURING PROCESS EFFICIENCY. THE PROPOSED CHANGES INCLUDE REMOVAL OF REDUNDANT TEST STEPS, SEPARATION OF COMPLEX ASSEMBLYOPERATIONS INTO SEVERAL DISCRETE STEPS, AND THE ADDITION OF AN IDENTICAL ASSEMBLY STATION.

    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