BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated Breast Ultrasound

    PMA: P110006 · Supplement: S005 · Decision Apr 13, 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
    S005
    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
    April 13, 2015
    Date Received
    February 27, 2015
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN APPLICATIONS TRAINING PROGRAM FOR THE INVENIA ABUS AUTOMATED BREAST ULTRASOUND SYSTEM. TWO ADDITIONAL TRAINING PROGRAMS WERE PROPOSED. THE FIRST ADDITION CONSISTS OF A ONE-DAY TRAINING PROGRAM FOR ONE TECHNOLOGIST/SCAN OPERATOR, EQUIVALENT TO THE PREVIOUSLY-APPROVED THREE-DAY PROGRAM FOR THREE TECHNOLOGISTS/SCAN OPERATORS. THE SECOND ADDITION CONSISTS OF A ONE-DAY TRAINING PROGRAM FOR A DESIGNATED SITEOPERATIONS SPECIALIST WHO IS EXPERIENCED IN INVENIA ABUS BREAST EXAMS, AND IS QUALIFIED FOR THE TRAINING ACCORDING TO A SET OF SPECIFIED REQUIREMENTS OUTLINED BY THE SPONSOR.

    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