Home GUDID M701TVIL1410140E1
Ovation Prime Abdominal Stent Graft System
Primary DI M701TVIL1410140E1
Brand Ovation Prime Abdominal Stent Graft System
Company Trivascular, Inc.
Model Iliac Limb
Catalog number TV-IL1410140-E
Device description 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.
Published 2014-07-15
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M701TVIL1410140E1 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Abdominal aorta endovascular stent-graft A non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA). It is percutaneously inserted via the femoral artery to the site of implantation, with a disposable delivery device, where it self-expands. It is typically made of nickel-titanium alloy (Nitinol) that forms an outer mesh structure with an inner polymer tube (endovascular graft). It is typically available in two designs: 1) a single continuous tube for insertion into one iliac artery; or 2) a two-part bifurcation design (e.g., shaped as a Y in a tube form) for insertion through both iliac arteries.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 13 French Length 140 Millimeter Outer Diameter 10 Millimeter Outer Diameter 14 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a cool, dry place.
Regulatory Flags# DUNS number 826179819 Device count 1 Lot or batch true Serial number true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M701TVAB2080E1 Ovation Prime Abdominal Stent Graft System Aortic Body TV-AB2080-E 2014-07-15 M701TVAB2080J1 Ovation iX Abdominal Stent Graft System Aortic Body TV-AB2080-J 2015-08-06 M701TVAB2380E1 Ovation Prime Abdominal Stent Graft System Aortic Body TV-AB2380-E 2014-07-15 M701TVAB2380J1 Ovation iX Abdominal Stent Graft System Aortic Body TV-AB2380-J 2015-08-06 M701TVAB2680E1 Ovation Prime Adominal Stent Graft System Aortic Body TV-AB2680-E 2014-07-15 M701TVAB2680J1 Ovation iX Abdominal Stent Graft System Aortic Body TV-AB2680-J 2015-08-06 M701TVAB2980E1 Ovation Prime Abdominal Stent Graft System Aortic Body TV-AB2980-E 2014-07-15 M701TVAB2980J1 Ovation iX Abdominal Stent Graft System Aortic Body TV-AB2980-J 2015-08-06 M701TVAB3480E1 Ovation Prime Abdominal Stent Graft System Aortic Body TV-AB3480-E 2014-07-15 M701TVAB3480J1 Ovation iX Abdominal Stent Graft System Aortic Body TV-AB3480-J 2015-08-06 M701TVAI01E1 Ovation Prime Abdominal Stent Graft System Autoinjector TV-AI01-E 2014-07-15 M701TVEX101045E1 Ovation Prime Abdominal Stent Graft System Iliac Extension TV-EX101045-E 2014-07-15 M701TVEX121245E1 Ovation Prime Abdominal Stent Graft System Iliac Extension TV-EX121245-E 2014-07-15 M701TVEX141445E1 Ovation Prime Abdominal Stent Graft System Iliac Extension TV-EX141445-E 2014-07-15 M701TVEX161645E1 Ovation Prime Abdominal Stent Graft System Iliac Extension TV-EX161645-E 2014-07-15 M701TVEX181845E1 Ovation Prime Abdominal Stent Graft System Iliac Extension TV-EX181845-E 2014-07-15 M701TVEX222245E1 Ovation Prime Abdominal Stent Graft System Iliac Extension TV-EX222245-E 2014-07-15 M701TVFP14E1 Ovation Prime Abdominal Stent Graft System Fill Polymer Kit TV-FP14-E 2014-07-15 M701TVIL1410100E1 Ovation Prime Abdominal Stent Graft System Iliac Limb TV-IL1410100-E 2014-07-15 M701TVIL1410120E1 Ovation Prime Abdominal Stent Graft System Iliac Limb TV-IL1410120-E 2014-07-15
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