Ovation Prime Abominal Stent Graft System TV-IL1412120-E

GUDID M701TVIL1412120E1

The TriVascular® Ovation Prime® Abdominal Stent Graft System 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 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
Primary Device IDM701TVIL1412120E1
NIH Device Record Key7666a756-fa22-48b2-8e44-e02321968d5f
Commercial Distribution StatusIn Commercial Distribution
Brand NameOvation Prime Abominal Stent Graft System
Version Model NumberIliac Limb
Catalog NumberTV-IL1412120-E
Company DUNS826179819
Company NameTrivascular, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter
Catheter Gauge13 French
Length120 Millimeter
Outer Diameter12 Millimeter
Outer Diameter14 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM701TVIL1412120E1 [Primary]

FDA Product Code

MIHSystem, Endovascular Graft, Aortic Aneurysm Treatment

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-12-21
Device Publish Date2014-07-15

Devices Manufactured by Trivascular, Inc.

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