- Device
- RelayPro Thoracic Stent-Graft System
- Applicant
- Bolton Medical, Inc.
- PMA number
- P200045
- Supplement
- S018
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2025-10-07
- Decision code
- APPR
- Date received
- 2025-06-16
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updates to the Instructions for Use (IFU) to include an additional bailout technique for the RelayPro Thoracic Stent-Graft System