- Device
- RelayPro Thoracic Stent-Graft System
- Applicant
- Bolton Medical, Inc.
- PMA number
- P200045
- Supplement
- S024
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2026-06-18
- Decision code
- OK30
- Date received
- 2026-05-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of a routine bacterial endotoxin testing facility for the RelayPro Thoracic Stent-Graft System and the TREO® Abdominal Stent-Graft System