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Zenith TX2 Thoracic Taa Endovascular Graft With The H&Lb One-Shot Introduction System

FDA PMA

Class III (US FDA PMA)

PMA P070016

by William Cook Europe ApS

Identity

Trade Name
ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM FDA PMA
Generic Name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT FDA PMA

Identifiers

PMA Number
P070016 FDA PMA
FDA Product Code
MIH FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APWD FDA PMA

The Zenith Tx2 Thoracic Taa Endovascular Graft With The H&Lb One-Shot Introduction System is a device for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta. It is designed for patients with vascular morphology suitable for endovascular repair, including adequate iliac/femoral access compatible with the required introduction systems.

The device is supplied as a single-use system and requires non-aneurysmal aortic segments proximal and distal to the aneurysm or ulcer with a length of at least 25 mm and a diameter measured outer wall to outer wall of no greater than 38 mm and no less than 24 mm. It has received FDA PMA approval for the treatment of thoracic aortic aneurysms.

Frequently asked questions

What is the purpose of the Zenith Tx2 Thoracic TAA Endovascular Graft?

The device is designed for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta, specifically for those with vascular morphology suitable for endovascular repair.

What are the vascular requirements for using this device?

Patients must have adequate iliac/femoral access compatible with the required introduction systems, and non-aneurysmal aortic segments proximal and distal to the aneurysm or ulcer with a length of at least 25 mm and a diameter between 24-38 mm.

Is the Zenith Tx2 Thoracic TAA Endovascular Graft reusable?

No, the device is supplied as a single-use system and should not be reused on multiple patients.

What regulatory approval has this device received?

The device has received FDA PMA approval for the treatment of thoracic aortic aneurysms.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ZENITH Watches - The Future of Swiss Watchmaking since 1865

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
William Cook Europe ApS

Sources (1)

  • FDA PMA P070016 24 fields · synced Sep 18, 2026