BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated Breast Ultrasound

    PMA: P110006 · Supplement: S002 · Decision Feb 11, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Automated Breast Ultrasound
    Trade Name
    INVENIA ABUS
    PMA Number
    P110006
    Supplement Number
    S002
    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
    February 11, 2014
    Date Received
    January 17, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGE IN THE LABELING MATERIALS (REVISED SCAN STATION USER¿S MANUAL, WORKSTATION USER¿S MANUAL, AND USER TRAINING PROGRAM, AS WELL AS NEW PATIENT POSITIONING GUIDE, QUICK REFERENCE GUIDE ¿ POSITIONING, PRODUCT DATASHEET, AND BASIC SERVICE MANUAL).

    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