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

    Automated Breast Ultrasound

    PMA: P110006 · Supplement: S006 · Decision Oct 15, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Automated Breast Ultrasound
    Trade Name
    INVENIA ABUS -- AUTOMATED BREAST ULTRASOUND SYSTEM
    PMA Number
    P110006
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    PAA
    Generic Name
    Automated breast ultrasound
    Medical Specialty
    Unknown
    Advisory Committee
    Radiology
    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

    CHANGES IN SUPPLIERS FOR 12 CRITICAL PARTS, TO IMPROVE THE PARTS' QUALITY, PRODUCTIVITY, AND DELIVERY. THE COMMON CHARACTERISTIC OF ALL 12 PARTS IS THEIR ELECTRICAL CONDUCTIVITY ON SPECIFIED SURFACES, TO ALLOW ELECTRICAL CONTINUITY FOR PROPER GROUNDING OF YOUR DEVICE. THE PROPOSED CHANGES DO NOT INVOLVE ANY CHANGES IN THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PAA Automated Breast Ultrasound