- Device
- Endurant Stent Graft Family
- Applicant
- Medtronic Vascular
- PMA number
- P100021
- Supplement
- S092
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2021-05-28
- Decision code
- APPR
- Date received
- 2021-04-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval to provide supplemental data from the ANCHOR Registry from an additional 60 subjects treated for short neck infrarenal aneurysms to provide support long-term safety and effectiveness data on the short neck indication