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Talent Thoracic Stent Graft System

FDA PMA

Class III (US FDA PMA)

PMA P070007

by Medtronic Vascular

Identity

Trade Name
TALENT THORACIC STENT GRAFT SYSTEM FDA PMA
Generic Name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT FDA PMA

Identifiers

PMA Number
P070007 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 Talent Thoracic Stent Graft System is a system for endovascular grafting, used for the treatment of aortic aneurysms. It is designed for the endovascular repair of fusiform aneurysms and saccular aneurysms/penetrating ulcers of the descending thoracic aorta. The system is indicated for patients having appropriate anatomy, including compatible iliac/femoral access vessel morphology and non-aneurysmal aortic diameter in the range of 18-42mm.

The Talent Thoracic Stent Graft System is supplied with various sizes and is intended for single-use. The system has received FDA PMA authorization. It is used in a cardiovascular setting, specifically for the treatment of descending thoracic aorta aneurysms. The system's use is subject to certain anatomical requirements, including non-aneurysmal aortic proximal and distal neck lengths >=20mm.

Frequently asked questions

What is the Talent Thoracic Stent Graft System used for?

The Talent Thoracic Stent Graft System is used for the endovascular repair of fusiform aneurysms and saccular aneurysms/penetrating ulcers of the descending thoracic aorta in patients with appropriate anatomy.

What are the anatomical requirements for the Talent Thoracic Stent Graft System?

The system is indicated for patients with iliac/femoral access vessel morphology compatible with vascular access techniques, non-aneurysmal aortic diameter in the range of 18-42mm, and non-aneurysmal aortic proximal and distal neck lengths >=20mm.

What type of authorization has the Talent Thoracic Stent Graft System received?

The Talent Thoracic Stent Graft System has received FDA PMA authorization.

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: Pivotal results of the Medtronic Vascular Talent Thoracic Stent ..., Pivotal results for the Medtronic Valiant Thoracic Stent Graft ..., Valiant™ Thoracic Stent Graft with Captivia™ Delivery System, Pivotal results of the Medtronic Vascular Talent Thoracic Stent ..., The Valiant Navion™ Thoracic Stent Graft System

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA PMA P070007 24 fields · synced Oct 6, 2026