- Device
- Endurant Stent Grafyt System, Endurant II Stent Graft System, Ednurant II AUI Stent Graft System, Endurant IIs Stent Gra
- Applicant
- Medtronic Vascular
- PMA number
- P100021
- Supplement
- S088
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2021-03-12
- Decision code
- OK30
- Date received
- 2021-03-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of new product label and component verification software for use on manufacturing lines in Medtronic Ireland.