BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Diagnostic Low Electric Field

    PMA: P110014 · Decision Dec 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Diagnostic Low Electric Field
    Trade Name
    DUNE MEDICAL DEVICES MARGINPROBE SYSTEM
    PMA Number
    P110014
    Device Class
    FDA Class 3
    Product Code
    OEE
    Generic Name
    Diagnostic low electric field
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 27, 2012
    Date Received
    April 4, 2011
    Expedited Review
    Y
    Docket Number
    13M-0036

    Advisory Committee Statement

    APPROVAL FOR THE MARGINPROBE SYSTEM. THIS DEVICE IS AN ADJUNCTIVE DIAGNOSTIC TOOL FOR IDENTIFICATION OF CANCEROUS TISSUE AT THE MARGINS (<= 1MM) OF THE MAIN EX-VIVO LUMPECTOMY SPECIMEN FOLLOWING PRIMARY EXCISION AND IS INDICATED FOR INTRAOPERATIVE USE, IN CONJUNCTION WITH STANDARD METHODS (SUCH AS INTRAOPERATIVE IMAGING AND PALPATION) IN PATIENTS UNDERGOING BREAST LUMPECTOMY SURGERY FOR PREVIOUSLY DIAGNOSED BREAST CANCER.

    Classifications

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

    Product Code Device Name
    OEE Diagnostic Low Electric Field