PMA P100021S094

Device: Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System, Endurant II AUI Stent Graf
Applicant: Medtronic Vascular
PMA number: P100021
Supplement: S094
Product code: MIH
Decision date: 2021-08-05
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Manufacturing changes to be implemented by the first-tier supplier (Phillips) of components for the delivery systems of Valiant Captivia and Endurant series devices.

Current openFDA PMA Record#

Device: Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System, Endurant II AUI Stent Graf
Applicant: Medtronic Vascular
PMA number: P100021
Supplement: S094
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2021-08-05
Decision code: OK30
Date received: 2021-07-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacturing changes to be implemented by the first-tier supplier (Phillips) of components for the delivery systems of Valiant Captivia and Endurant series devices.