PMA P100021S101

Device: Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIS Stent Graft System
Applicant: Medtronic Vascular
PMA number: P100021
Supplement: S101
Product code: MIH
Decision date: 2022-02-24
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Implementation of temporary visual inspection for sorting finished Endurant devices within scope of a field corrective action.

Current openFDA PMA Record#

Device: Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIS Stent Graft System
Applicant: Medtronic Vascular
PMA number: P100021
Supplement: S101
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2022-02-24
Decision code: OK30
Date received: 2022-01-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of temporary visual inspection for sorting finished Endurant devices within scope of a field corrective action.