PMA P250033S002

Device: NEXUS Aortic Arch Stent Graft System
Applicant: Endospan , Ltd.
PMA number: P250033
Supplement: S002
Product code: SDZ
Decision date: 2026-07-24
Classification: Cardiovascular
Generic name: Endovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions
Approval order statement: approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P250033.

Current openFDA PMA Record#

Device: NEXUS Aortic Arch Stent Graft System
Applicant: Endospan , Ltd.
PMA number: P250033
Supplement: S002
Product code: SDZ
Generic name: Endovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions
Decision date: 2026-07-24
Decision code: APPR
Date received: 2026-04-30
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P250033.