PMA P190015S026

Device: TREO® Abdominal Stent-Graft System
Applicant: Bolton Medical, Inc.
PMA number: P190015
Supplement: S026
Product code: MIH
Decision date: 2026-03-26
Classification: Cardiovascular
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: approval for the addition of 140mm contralateral length TREO Main Bifurcated Stent Graft size and modifications to the TREO B2/C2 delivery system

Current openFDA PMA Record#

Device: TREO® Abdominal Stent-Graft System
Applicant: Bolton Medical, Inc.
PMA number: P190015
Supplement: S026
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2026-03-26
Decision code: APPR
Date received: 2025-09-30
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for the addition of 140mm contralateral length TREO Main Bifurcated Stent Graft size and modifications to the TREO B2/C2 delivery system