PMA P250033S004
- Device
- NEXUS Aortic Arch Stent Graft System
- Applicant
- Endospan , Ltd.
- PMA number
- P250033
- Supplement
- S004
- Product code
- SDZ
- Decision date
- 2026-09-21
- Classification
- Cardiovascular
- Generic name
- Endovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions
- Approval order statement
- approval for a 3 year shelf-life for the NEXUS Aortic Arch Stent Graft System
Current openFDA PMA Record#
- Device
- NEXUS Aortic Arch Stent Graft System
- Applicant
- Endospan , Ltd.
- PMA number
- P250033
- Supplement
- S004
- Product code
- SDZ
- Generic name
- Endovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions
- Decision date
- 2026-09-21
- Decision code
- APPR
- Date received
- 2026-06-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for a 3 year shelf-life for the NEXUS Aortic Arch Stent Graft System