PMA P100021S132
- Device
- Endurant™ II/IIs Stent Graft System
- Applicant
- Medtronic Vascular
- PMA number
- P100021
- Supplement
- S132
- Product code
- MIH
- Decision date
- 2026-05-12
- Classification
- Cardiovascular
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- approval for updates to the labeling to reflect the 60-month data from the ANCHOR Registry Short Neck Cohort
Current openFDA PMA Record#
- Device
- Endurant™ II/IIs Stent Graft System
- Applicant
- Medtronic Vascular
- PMA number
- P100021
- Supplement
- S132
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2026-05-12
- Decision code
- APPR
- Date received
- 2025-10-27
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- approval for updates to the labeling to reflect the 60-month data from the ANCHOR Registry Short Neck Cohort