PMA P100021S109

Device: Endurant Stent Graft System, Endurant II Stent Graft System, Eudurant IIs Stent Graft System, Endurant II Aorto-Uni-Ilia
Applicant: Medtronic Vascular
PMA number: P100021
Supplement: S109
Product code: MIH
Decision date: 2022-11-30
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Implementation of a graft coupon permeability specification for the Endurant Stent Graft System, Endurant II Stent Graft System, Eudurant IIs Stent Graft System and Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System.

Current openFDA PMA Record#

Device: Endurant Stent Graft System, Endurant II Stent Graft System, Eudurant IIs Stent Graft System, Endurant II Aorto-Uni-Ilia
Applicant: Medtronic Vascular
PMA number: P100021
Supplement: S109
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2022-11-30
Decision code: OK30
Date received: 2022-11-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of a graft coupon permeability specification for the Endurant Stent Graft System, Endurant II Stent Graft System, Eudurant IIs Stent Graft System and Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System.