PMA P120006S045

Device: Alto Abdominal Stent Graft System
Applicant: Endologix, LLC
PMA number: P120006
Supplement: S045
Product code: MIH
Decision date: 2026-06-03
Classification: Cardiovascular
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: approval of changes to the supplier performing processing of the nitinol wire used in manufacturing of the Alto device.

Current openFDA PMA Record#

Device: Alto Abdominal Stent Graft System
Applicant: Endologix, LLC
PMA number: P120006
Supplement: S045
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2026-06-03
Decision code: APPR
Date received: 2025-09-08
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval of changes to the supplier performing processing of the nitinol wire used in manufacturing of the Alto device.