TREO® Abdominal Stent-Graft System
FDA premarket approval P190015 · decided 2020-05-04
Approval details
- PMA number
- P190015
- Trade name
- 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
- Days to decision
- 336 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sunrise, FL
- Statement
- 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 accessories;2. Proximal aortic landing zone with: 2a. Infrarenal landing neck length of >= 15mm; 2b. Aortic neck diameters >= 17 mm and <= 32 mm; 2c. Suprarenal neck angle of <= 45 degrees; 2d. In
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BOLTON PTA CATHETER (K021996) | Bolton Medical, Inc. | 2002-08-23 |