|
Device | RelayPro Thoracic Stent-Graft System |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Bolton Medical, Inc. 799 International Parkway Sunrise, FL 33325 |
PMA Number | P200045 |
Date Received | 11/20/2020 |
Decision Date | 08/05/2021 |
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 |
Recalls | CDRH Recalls |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S006 S008 S009 S010 S011 |