f909c620-75c4-4c2d-a77c-97e19c943fceUpdatePublished62024-12-112019-06-132023-06-13Not in Commercial Distribution08435761002154PrimaryGS1Relay Plus Thoracic Stent-Graft System28-M346250462690U28-M346250462690U847424462Bolton Medical Inc.1Endovascular stent-graft systemfalsefalsefalsefalsefalsetruetruefalsetruetruefalsefalsefalseMR ConditionaltruefalseP110038000P110038001P110038002P110038004P110038005P110038006P110038008P110038009P110038010P110038011P110038012P110038013P110038014P110038015P110038016P110038017P110038018P110038020P110038021P110038022P110038023P110038024P110038025P110038026P110038027P110038029P110038030P110038031P11003803248060Descending thoracic aorta endovascular stent-graftA non-bioabsorbable tubular device intended to be implanted within the descending thoracic aorta to repair the vessel [includes repair of thoracic aortic aneurysm (TAA), traumatic transsections/dissections, fistulae, penetrating ulcers]; it is not intended for implantation within the aortic arch. It is typically made of a metal alloy [e.g., nickel-titanium alloy (Nitinol)] that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft) and is typically designed as a single continuous tube which may be used in singular and/or modular configurations. It is intended for percutaneous introduction; disposable delivery device (e.g., balloon catheter) may be included.trueActiveMIHSystem, Endovascular Graft, Aortic Aneurysm TreatmentOuter DiameterLengthCatheter GaugeStorage Environment Temperaturetruefalse