PMA P190015S024

Device: TREO® Abdominal Stent-Graft System
Applicant: Bolton Medical, Inc.
PMA number: P190015
Supplement: S024
Product code: MIH
Decision date: 2026-04-13
Classification: Cardiovascular
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Approval for a change in the inner liner material of the introducer sheath for the Relay®Pro Thoracic Stent-Graft System and TREO® Abdominal Stent-Graft System.

Current openFDA PMA Record#

Device: TREO® Abdominal Stent-Graft System
Applicant: Bolton Medical, Inc.
PMA number: P190015
Supplement: S024
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2026-04-13
Decision code: APPR
Date received: 2025-06-06
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a change in the inner liner material of the introducer sheath for the Relay®Pro Thoracic Stent-Graft System and TREO® Abdominal Stent-Graft System.