BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated Breast Ultrasound

    PMA: P110006 · Supplement: S008 · Decision Sep 7, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Automated Breast Ultrasound
    Trade Name
    Invenia ABUS Autoated Breast Ultrasound System
    PMA Number
    P110006
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    PAA
    Generic Name
    Automated breast ultrasound
    Medical Specialty
    Unknown
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 7, 2017
    Date Received
    February 28, 2017
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site change to GE Parallel Design Inc., 4313 E Cotton Center Blvd., Suite 100, Phoenix Arizona.

    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