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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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.
ENDOLOGIX, INC.
Iliac Limb
In Commercial Distribution

  • M701TVIL1428120J1 ()

  • Catheter Gauge: 15 French
  • Length: 120 Millimeter
  • Outer Diameter: 28 Millimeter
  • Outer Diameter: 14 Millimeter
TV-IL1428120-J

  • Abdominal aorta endovascular stent-graft
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.
ENDOLOGIX, INC.
Iliac Limb
In Commercial Distribution

  • M701TVIL1428100J1 ()

  • Catheter Gauge: 15 French
  • Length: 100 Millimeter
  • Outer Diameter: 28 Millimeter
  • Outer Diameter: 14 Millimeter
TV-IL1428100-J

  • Abdominal aorta endovascular stent-graft
Hemashield Platinum Woven 4 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Accessory
INTERVASCULAR SAS
M00202175928P0
In Commercial Distribution

  • 00384401018650 ()

  • Lumen/Inner Diameter: 8 Millimeter
  • Lumen/Inner Diameter: 10 Millimeter
  • Lumen/Inner Diameter: 28 Millimeter
  • Length: 50 Centimeter
M00202175928P0

  • Synthetic vascular graft
Intergard Woven Hemabridge Collagen Coated Vascular Graft
INTERVASCULAR SAS
HEW2810BRIDGE
In Commercial Distribution

  • 00384401001010 ()

  • Lumen/Inner Diameter: 10 Millimeter
  • Lumen/Inner Diameter: 28 Millimeter
  • Length: 40 Centimeter
  • Length: 35 Centimeter
HEW2810BRIDGE

  • Synthetic vascular graft
Hemashield Platinum Woven ThoracoAbdominal 4 Branch Double Velour Vascular Graft with Graft Sizer Accessory
INTERVASCULAR SAS
M00202175428T0
In Commercial Distribution

  • 00384401018773 ()

  • Lumen/Inner Diameter: 8 Millimeter
  • Lumen/Inner Diameter: 10 Millimeter
  • Lumen/Inner Diameter: 28 Millimeter
  • Length: 47 Centimeter
M00202175428T0

  • Synthetic vascular graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-M4-24-250-28U
In Commercial Distribution

  • 00843576153820 ()

  • Outer Diameter: 24 Millimeter
  • Outer Diameter: 28 Millimeter
  • Length: 264 Millimeter
  • Catheter Gauge: 19 French
28-M4-24-250-28U

  • Descending thoracic aorta endovascular stent-graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-M4-24-230-28U
In Commercial Distribution

  • 00843576153813 ()

  • Outer Diameter: 24 Millimeter
  • Outer Diameter: 28 Millimeter
  • Length: 244 Millimeter
  • Catheter Gauge: 19 French
28-M4-24-230-28U

  • Descending thoracic aorta endovascular stent-graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-M4-24-210-28U
In Commercial Distribution

  • 00843576153806 ()

  • Outer Diameter: 24 Millimeter
  • Outer Diameter: 28 Millimeter
  • Length: 224 Millimeter
  • Catheter Gauge: 19 French
28-M4-24-210-28U

  • Descending thoracic aorta endovascular stent-graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-M4-24-190-28U
In Commercial Distribution

  • 00843576153790 ()

  • Outer Diameter: 24 Millimeter
  • Outer Diameter: 28 Millimeter
  • Length: 204 Millimeter
  • Catheter Gauge: 19 French
28-M4-24-190-28U

  • Descending thoracic aorta endovascular stent-graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-M4-24-170-28U
In Commercial Distribution

  • 00843576153783 ()

  • Outer Diameter: 24 Millimeter
  • Outer Diameter: 28 Millimeter
  • Length: 184 Millimeter
  • Catheter Gauge: 19 French
28-M4-24-170-28U

  • Descending thoracic aorta endovascular stent-graft
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