PMA P100021S133

Device: Endurant Stent Graft System; Endurant II/IIs Stent Graft System; Endurant II AUI Stent Graft System
Applicant: Medtronic Vascular
PMA number: P100021
Supplement: S133
Product code: MIH
Decision date: 2026-01-27
Classification: Cardiovascular
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: replication of the graft material supplier’s post-weaving manufacturing steps at an alternate manufacturing location

Current openFDA PMA Record#

Device: Endurant Stent Graft System; Endurant II/IIs Stent Graft System; Endurant II AUI Stent Graft System
Applicant: Medtronic Vascular
PMA number: P100021
Supplement: S133
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2026-01-27
Decision code: OK30
Date received: 2026-01-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: replication of the graft material supplier’s post-weaving manufacturing steps at an alternate manufacturing location