Approval for treo® abdominal stent-graft system. This device is indicated for use in the endovascular treatment of patients with infrarenal abdominal aortic and aorto-iliac aneurysms with the following characteristics:1. Adequate iliac or femoral access compatible with the required delivery systems and accessories2. Proximal aortic landing zone with:2a. Infrarenal landing neck length of >= 15mm2b. Aortic neck diameters >= 17 mm and = 15 mm4. Minimum overall aaa treatment length (proximal landing location to distal landing location) of 13 cm5. Minimum overall length from the lowest renal artery to the aortic bifurcation of 9 cm
| Device | TREO® Abdominal Stent-Graft System |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | Bolton Medical Inc. |
| Date Received | 2019-06-03 |
| Decision Date | 2020-05-04 |
| PMA | P190015 |
| Supplement | S |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bolton Medical Inc. 799 International Pkwy sunrise, FL 33325 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190015 | Original Filing | |
| S010 | 2022-12-23 | Special (immediate Track) |
| S009 | 2021-01-25 | Real-time Process |
| S008 | 2020-11-24 | 30-day Notice |
| S007 | 2020-11-23 | Normal 180 Day Track No User Fee |
| S006 | 2020-10-29 | 30-day Notice |
| S005 | 2020-09-14 | 30-day Notice |
| S004 | ||
| S003 | ||
| S002 | 2020-07-23 | Special (immediate Track) |
| S001 | 2020-06-03 | Normal 180 Day Track No User Fee |