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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRelayPro Thoracic Stent-Graft System
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantBolton Medical, Inc.
799 International Parkway
Sunrise, FL 33325
PMA NumberP200045
Supplement NumberS002
Date Received05/16/2022
Decision Date03/07/2023
Product Code MIH 
Docket Number 23M-0852
Notice Date 03/09/2023
Advisory Committee Cardiovascular
Clinical TrialsNCT03090230
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order 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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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