Endurant II/IIs Stent Graft System
FDA premarket approval P100021/S132 · decided 2026-05-12
Approval details
- PMA number
- P100021
- Supplement
- S132
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Endurant II/IIs Stent Graft System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2025-10-27
- Decision date
- 2026-05-12
- Days to decision
- 197 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- approval for updates to the labeling to reflect the 60-month data from the ANCHOR Registry Short Neck Cohort
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