RelayPro Thoracic Stent-Graft System
FDA premarket approval P200045/S002 · decided 2023-03-07
Approval details
- PMA number
- P200045
- Supplement
- S002
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RelayPro Thoracic Stent-Graft System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Bolton Medical, Inc.
- Date received
- 2022-05-16
- Decision date
- 2023-03-07
- Days to decision
- 295 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sunrise, FL
- Statement
- Approval of the RelayPro Thoracic Stent Graft System for treatment of all lesions of the descending thoracic aorta. The RelayPro Thoracic Stent-Graft System is indicated for the endovascular repair of all lesions of the descending thoracic aorta in patients having appropriate anatomy, including:1) Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories;2) Non-aneurysmal aortic neck diameter in the range of 20 to 42 mm (fusiform an
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BOLTON PTA CATHETER (K021996) | Bolton Medical, Inc. | 2002-08-23 |