Ovation iX Iliac Stent Graft - The TriVascular® Ovation Prime® Abdominal Stent - ENDOLOGIX, INC.

Duns Number:858560477

Device Description: The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Ste The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent Graft is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required.The TriVascular Ovation Prime Abdominal Stent Graft System with the Ovation iX Iliac Stent Graft includes, an Aortic Body Stent Graft and delivery catheter, Iliac Limb Stent Grafts and delivery catheters, Iliac Extension Stent Grafts and delivery catheters, as required, a Fill Polymer Kit, and an Autoinjector.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

TV-IL1414100-J

Brand Name

Ovation iX Iliac Stent Graft

Version/Model Number

Iliac Limb

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P120006,P120006,P120006,P120006

Product Code Details

Product Code

MIH

Product Code Name

System, Endovascular Graft, Aortic Aneurysm Treatment

Device Record Status

Public Device Record Key

473285ee-6b51-424a-adb9-6741fce6a04e

Public Version Date

April 08, 2022

Public Version Number

7

DI Record Publish Date

March 05, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ENDOLOGIX, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1
3 A medical device with high risk that requires premarket approval 277