BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transcatheter Septal Occluder

    PMA: P050006 · Decision Aug 11, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Transcatheter Septal Occluder
    Trade Name
    GORE HELEX SEPTAL OCCLUDER
    PMA Number
    P050006
    Device Class
    FDA Class 3
    Product Code
    MLV
    Generic Name
    Transcatheter septal occluder
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 11, 2006
    Date Received
    March 1, 2005
    Expedited Review
    N
    Docket Number
    06M-0341

    Advisory Committee Statement

    APPROVAL FOR THE GORE HELEX SEPTAL OCCLUDER. THE DEVICE IS A PERMANENTLY IMPLANTED PROSTHESIS INDICATED FOR THE PERCUTANEOUS, TRANSCATHETER CLOSER OF OSTIUM SECUNDUM ATRIAL SEPTAL DEFECTS (ASDS).

    Classifications

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

    Product Code Device Name
    MLV Transcatheter Septal Occluder