PMA P190015S030

Device: TREO® Abdominal Stent-Graft System
Applicant: Bolton Medical, Inc.
PMA number: P190015
Supplement: S030
Product code: MIH
Decision date: 2026-06-18
Classification: Cardiovascular
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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

Current openFDA PMA Record#

Device: TREO® Abdominal Stent-Graft System
Applicant: Bolton Medical, Inc.
PMA number: P190015
Supplement: S030
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