Ovation Prime Abdominal Stent Graft System TV-IL141080-E

GUDID M701TVIL141080E1

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 IDM701TVIL141080E1
NIH Device Record Keyea2ac144-283d-42e7-a896-6b4a7a26caa6
Commercial Distribution StatusIn Commercial Distribution
Brand NameOvation Prime Abdominal Stent Graft System
Version Model NumberIliac Limb
Catalog NumberTV-IL141080-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
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 Millimeter
Catheter Gauge13 French
Length80 Millimeter
Outer Diameter14 Millimeter
Outer Diameter10 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.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM701TVIL141080E1 [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

On-Brand Devices [Ovation Prime Abdominal Stent Graft System]

M701TVIL142280E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL1422140E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL1422120E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL1422100E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL141880E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL1418140E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL1418120E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL1418100E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL141680E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL1416140E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL1416120E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL1416100E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL141480E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL1414140E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL1414120E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL1414100E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL141280E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL1412140E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL1412100E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL141080E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL1410140E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL1410120E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVIL1410100E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVFP14E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVEX222245E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVEX181845E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVEX161645E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVEX141445E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVEX121245E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVEX101045E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVCS14G1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVAI01E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVAB3480E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVAB2980E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVAB2380E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver
M701TVAB2080E1The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver

Trademark Results [Ovation Prime Abdominal Stent Graft System]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
85832445 4449077 Live/Registered
TriVascular, Inc.
2013-01-25
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