NEXUS Aortic Arch Stent Graft System
by Endospan Ltd
PMA P250033
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP250033 | Date2 Apr 2026 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Endovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions
- FDA applicant
- Endospan , Ltd.
- PMA Number
- FDA Product Code
- SDZ
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Nexus Aortic Arch Stent Graft System is an endovascular device classified as an Endovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions. It is designed to treat chronic dissections in the aortic arch through minimally invasive endovascular techniques, providing structural support to the vessel wall while reducing the risk of complications associated with open surgical repair.
This system is supplied as a sterile, single-use device intended for use in high-risk patients with suitable anatomy. It is regulated under FDA Premarket Approval (PMA) with approval number P250033, and its use requires specialized interventional radiology or cardiovascular surgery settings. The device is delivered via catheter-based deployment and is compatible with standard imaging modalities, including fluoroscopy and CT angiography. Storage and handling follow sterile medical device protocols to ensure integrity prior to use.