BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P040043 · Supplement: S031 · Decision Mar 23, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    GORE TAG THORACIC ENDOPROSTHESIS
    PMA Number
    P040043
    Supplement Number
    S031
    Device Class
    FDA Class 3
    Product Code
    MIH
    Generic Name
    SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 23, 2010
    Date Received
    September 24, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDING THE 45MM TAG THORACIC ENDOPROSTHESIS TO THE ALREADY EXISTING TAG THORACIC ENDOPROSTHESIS PRODUCT FAMILY. THE TAG DEVICE IS INDICATED FOR ENDOVASCULAR REPAIR OF ANEURYSMS OF THE DESCENDING THORACIC AORTA IN PATIENTS WHO HAVE APPROPRIATE ANATOMY, INCLUDING ADEQUATE ILIAC/ FEMORAL ACCESS, AORTIC INNER DIAMETER IN THE RANGE OF 23-42MM, AND >=2CM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE ANEURYSM.

    Classifications

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

    Product Code Device Name
    MIH System, Endovascular Graft, Aortic Aneurysm Treatment