BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P040043 · Supplement: S051 · Decision Sep 10, 2013
    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
    S051
    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
    September 10, 2013
    Date Received
    March 14, 2013
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    13M-1323

    Advisory Committee Statement

    APPROVAL FOR THE GORE TAG THORACIC ENDOPROSTHESIS. THIS DEVICE IS INTENDED FOR ENDOVASCULAR REPAIR OF ALL LESIONS OF THE DESCENDING THORACIC AORTA, INCLUDING:1) ISOLATED LESIONS IN PATIENTS WHO HAVE APPROPRIATE ANATOMY, INCLUDING:A) ADEQUATE ILIAC I FEMORAL ACCESS;B) AORTIC INNER DIAMETER IN THE RANGE OF 16-42 MM; AND C) > 20 MM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE LESION.2) TYPE B DISSECTIONS IN PATIENTS WHO HAVE APPROPRIATE ANATOMY, INCLUDING:A) ADEQUATE ILIAC I FEMORAL ACCESS;B) > 20 MM LANDING ZONE PROXIMAL TO THE PRIMARY ENTRY TEAR; PROXIMAL EXTENT OF THE LANDING ZONE MUST NOT BE DISSECTED; ANDC) DIAMETER AT PROXIMAL EXTENT OF PROXIMAL LANDING ZONE IN THE RANGE OF 16-42 MM.

    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