BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P200045 · Supplement: S002 · Decision Mar 7, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    RelayPro Thoracic Stent-Graft System
    PMA Number
    P200045
    Supplement Number
    S002
    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 7, 2023
    Date Received
    May 16, 2022
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    23M-0852

    Advisory Committee Statement

    Approval of the RelayPro Thoracic Stent Graft System for treatment of all lesions of the descending thoracic aorta. The RelayPro Thoracic Stent-Graft System is indicated for the endovascular repair of all lesions of the descending thoracic aorta in patients having appropriate anatomy, including:1) Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories;2) Non-aneurysmal aortic neck diameter in the range of 20 to 42 mm (fusiform aneurysms and saccular aneurysms/penetrating atherosclerotic ulcers) or proximal and distal landing zones with diameters between 19 to 42 mm (traumatic aortic injuries);3) Non-aneurysmal proximal aortic neck lengths (fusiform aneurysms and saccular aneurysms/penetrating atherosclerotic ulcers) or landing zones (traumatic aortic injuries) of: a. 15 mm for the 22 to 28 mm device diameters (Bare Stent Configuration) b. 20 mm for the 30 to 38 mm device diameters (Bare Stent Configuration) c. 25 mm for the 40 to 46 mm device diameters (Bare Stent Configuration) d. 25 mm for the 22 to 38 mm device diameters (Non-Bare Stent Configuration) e. 30 mm for the 40 to 46 mm device diameters (Non-Bare Stent Configuration)4) Non-aneurysmal distal aortic neck lengths (fusiform aneurysms and saccular aneurysms/penetrating atherosclerotic ulcers) of: a. 25 mm for the 24 to 38 mm device diameters b. 30 mm for the 40 to 46 mm device diameters5) Non-aneurysmal distal landing zone of 20 mm for traumatic aortic injuries (22 to 46mm device diameters) and dissections (24 to 46mm device diameters)The RelayPro Thoracic Stent-Graft System (NBS configuration) is indicated for the endovascular distal extension of the Thoraflex Hybrid device.

    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