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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceRelayPro Thoracic Stent-Graft System
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
Bolton Medical, Inc.
799 international parkway
sunrise, FL 33325
PMA NumberP200045
Date Received11/20/2020
Decision Date08/05/2021
Product Code MIH 
Docket Number 21M-0805
Notice Date 08/16/2021
Advisory Committee Cardiovascular
Clinical Trials NCT02818972
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for The Relay®Pro Thoracic Stent-Graft System. The device is indicated for the endovascular repair of fusiform aneurysms and saccular aneurysms/penetrating atherosclerotic ulcers in the descending thoracic aorta in patients having appropriate anatomy, including:-- Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories;-- Non-aneurysmal aortic neck diameter in the range of 20 to 42 mm; and -- Non-aneurysmal proximal aortic neck lengths of: 15 mm for the 24 to 28 mm Bare Stent Configuration device diameters 20 mm for the 30 to 38 mm Bare Stent Configuration device diameters 25 mm for the 40 to 46 mm Bare Stent Configuration device diameters 25 mm for the 24 to 38 mm Non-Bare Stent Configuration device diameters 30 mm for the 40 to 46 mm Non-Bare Stent Configuration device diameters Non-aneurysmal distal aortic neck lengths of: 25 mm for the 24 to 38 mm device diameters 30 mm for the 40 to 46 mm device diameters.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 
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