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Ovation and Ovation Prime Abdominal Stent Graft System

FDA PMA

Class III (US FDA PMA)

PMA P120006

by Endologix LLC

Identity

Trade Name
OVATION ABDOMINAL STENT GRAFT SYSTEM FDA PMA
Generic Name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT FDA PMA

Identifiers

PMA Number
P120006 FDA PMA
FDA Product Code
MIH FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APPR Approved FDA PMA

The Ovation and Ovation Prime Abdominal Stent Graft System is an endovascular graft designed for the treatment of patients with abdominal aortic aneurysms. It is indicated for use in patients with vascular morphology suitable for endovascular repair, including specific requirements for proximal aortic neck length, diameter, and angulation, as well as adequate distal iliac landing zones.

This device is intended for use in patients who have adequate iliac or femoral access compatible with standard vascular access techniques and accessories. The system has received FDA PMA approval for clinical use. Please consult the product labeling for detailed specifications regarding anatomical requirements and procedural compatibility.

Frequently asked questions

What is the primary indication for the Ovation Stent Graft System?

The system is indicated for the treatment of patients diagnosed with abdominal aortic aneurysms who possess vascular morphology suitable for endovascular repair.

Are there specific anatomical requirements for using this device?

Yes, the device requires specific anatomical criteria, including a proximal aortic neck length of at least 7 mm, an inner wall diameter between 16 mm and 30 mm, and defined aortic angle limits based on neck length. Additionally, it requires an adequate distal iliac landing zone with a length of at least 10 mm and an inner wall diameter between 8 mm and 20 mm.

Has this device received regulatory authorization?

Yes, the Ovation Abdominal Stent Graft System has received FDA PMA approval for use in the treatment of abdominal 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Endologix LLC
FDA Applicant
Endologix, LLC

Sources (1)

  • FDA PMA P120006 24 fields · synced Oct 6, 2026