BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P100040 · Supplement: S036 · Decision Oct 19, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    Valiant Navion Thoracic Stent Graft System
    PMA Number
    P100040
    Supplement Number
    S036
    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
    October 19, 2018
    Date Received
    April 23, 2018
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    18M-4033

    Advisory Committee Statement

    Approval of the Valiant Navion Thoracic Stent Graft System, a modified device design from the Valiant Thoracic Stent Graft with Captivia Delivery System. This device is indicated for all lesions of the descending thoracic aorta (DTA) in patients having appropriate anatomy: 1) iliac or femoral artery access vessel morphology that is compatible with vascular access techniques, devices, or accessories;2) nonaneurysmal aortic diameter in the range of: 16 mm to 42 mm for fusiform and saccular aneurysms/penetrating ulcers, 16 mm to 44 mm for blunt traumatic aortic injuries, 19 mm to 45 mm for dissections; 3) proximal landing zone (nonaneurysmal aortic proximal neck length for fusiform and saccular aneurysms/penetrating ulcers or nondissected length of aorta proximal to the primary tear for blunt traumatic aortic injuries and dissections) of: >= 20mm for FreeFlo configuration and ?>=25mm for CoveredSeal configuration; and 4) nonaneurysmal aortic distal neck length >= 20mm for FreeFlo and CoveredSeal configurations for fusiform and saccular aneurysms/penetrating ulcers.

    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