Ovation iX Iliac Stent Graft TV-EX181845-J

GUDID M701TVEX181845J1

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.

Trivascular, Inc.

Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated

Primary Device ID	M701TVEX181845J1
NIH Device Record Key	213a482c-4ea7-498f-9a09-21d940dd277b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Ovation iX Iliac Stent Graft
Version Model Number	Iliac Extension
Catalog Number	TV-EX181845-J
Company DUNS	826179819
Company Name	Trivascular, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter
Catheter Gauge	13 French
Length	45 Millimeter
Outer Diameter	18 Millimeter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M701TVEX181845J1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P120006

FDA Product Code

MIH	System, Endovascular Graft, Aortic Aneurysm Treatment

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2020-12-21
Device Publish Date	2015-03-05

On-Brand Devices [Ovation iX Iliac Stent Graft]

M701TVIL142880J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1428160J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1428140J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1428120J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1428100J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL142280J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1422160J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1422140J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1422120J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1422100J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL141880J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1418160J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1418140J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1418120J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1418100J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL141680J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1416160J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1416140J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1416120J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1416100J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL141480J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1414160J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1414140J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1414120J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1414100J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL141280J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1412160J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1412140J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1412120J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1412100J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL141080J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1410160J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1410140J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1410120J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVIL1410100J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVEX282845J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVEX222245J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVEX181845J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVEX161645J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVEX141445J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVEX121245J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G
M701TVEX101045J1	The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent G