- Device
- Endurant II Stent Graft System, Endurant II Aort-Uni-Illac (AUI) Stent Graft System, Endurant IIs Stent Graft System, En
- Applicant
- Medtronic Vascular
- PMA number
- P100021
- Supplement
- S100
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2022-02-07
- Decision code
- OK30
- Date received
- 2022-01-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of a third tier supplier from the manufacturing of Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System and Endurant IIs Stent Graft System.