The relay®pro thoracic stent-graft system 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:o iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories;o non-aneurysmal aortic neck diameter in the range of 20 – 42 mm; o non-aneurysmal proximal aortic neck lengths of: 15 mm for the 24 – 28 mm bare stent configuration device diameters 20 mm for the 30 – 38 mm bare stent configuration device diameters 25 mm for the 40 – 46 mm bare stent configuration device diameters 25 mm for the 24 – 38 mm non-bare stent configuration device diameters 30 mm for the 40 – 46 mm non-bare stent configuration device diameters non-aneurysmal distal aortic neck lengths of: 25 mm for the 24 – 38 mm device diameters 30 mm for the 40 – 46 mm device diameters
Device | RelayPro Thoracic Stent-Graft System |
Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
Applicant | Bolton Medical, Inc. |
Date Received | 2020-11-20 |
Decision Date | 2021-08-05 |
PMA | P200045 |
Supplement | S |
Product Code | MIH |
Advisory Committee | Cardiovascular |
Expedited Review | No |
Combination Product | No |
Applicant Address | Bolton Medical, Inc. 799 International Parkway sunrise, FL 33325 |
Supplement Number | Date | Supplement Type |
---|---|---|
P200045 | Original Filing | |
S003 | 2022-07-12 | 30-day Notice |
S002 | ||
S001 | 2021-09-03 | Normal 180 Day Track No User Fee |