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Ovation iX Abdominal Stent Graft System

FDA UDI

Class III (US FDA UDI)

by Trivascular, Inc.

Identity

Trade Name
Ovation iX Abdominal Stent Graft System FDA UDI
Generic Name
Aortoiliac endovascular stent-graft FDA UDI
Device Name
The TriVascular® Ovation iX™ Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal stent graft 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 iX Abdominal Stent Graft System 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 Kit, and an Autoinjector. FDA UDI
Model / Reference
Aortic Body FDA UDI
Description
The TriVascular® Ovation iX™ Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal stent graft 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 iX Abdominal Stent Graft System 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 Kit, and an Autoinjector. FDA UDI

Identifiers

Catalog Number
TV-AB3480-J FDA UDI
Primary DI / UDI-DI
M701TVAB3480J1 FDA UDI
PMA Number
P120006 FDA UDI
FDA Product Code
MIH FDA UDI
GMDN Term
Aortoiliac endovascular stent-graft FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 34 Millimeter FDA UDI
Catheter Gauge — 15 French FDA UDI

Category: Aortoiliac endovascular stent-graft

Ovation iX Abdominal Stent Graft System by Trivascular, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Aortoiliac endovascular stent-graft.

Cleared under the same submission

P120006 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Trivascular, Inc.

Sources (1)

  • FDA UDI 1a881cc7-16cd-4ae0-9970-51103efac814 37 fields · synced Jun 8, 2026