PMA P190015S027
- Device
- TREO® Abdominal Stent-Graft System
- Applicant
- Bolton Medical, Inc.
- PMA number
- P190015
- Supplement
- S027
- Product code
- MIH
- Decision date
- 2026-02-18
- Classification
- Cardiovascular
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- approval for design changes to the distal cap and threaded collar of the TREO Abdominal Stent-Graft delivery system
Current openFDA PMA Record#
- Device
- TREO® Abdominal Stent-Graft System
- Applicant
- Bolton Medical, Inc.
- PMA number
- P190015
- Supplement
- S027
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2026-02-18
- Decision code
- APPR
- Date received
- 2025-11-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for design changes to the distal cap and threaded collar of the TREO Abdominal Stent-Graft delivery system