PMA P250033

Device: NEXUS® Aortic Arch Stent Graft System
Applicant: Endospan , Ltd.
PMA number: P250033
Supplement: S001
Product code: SDZ
Decision date: 2026-05-20
Classification: Cardiovascular
Generic name: Endovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions
Approval order statement: implementation of a new clean room and associated controlled areas for manufacturing of 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: S001
Product code: SDZ
Generic name: Endovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions
Decision date: 2026-05-20
Decision code: OK30
Date received: 2026-04-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementation of a new clean room and associated controlled areas for manufacturing of the Nexus Aortic Arch Stent Graft System