Ovation Prime Abdominal Stent Graft System TV-CS14-G
GUDID M701TVCS14G1
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 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 | M701TVCS14G1 |
| NIH Device Record Key | dcca5dfb-8a7c-4019-adbc-3e4ac5dcc1a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ovation Prime Abdominal Stent Graft System |
| Version Model Number | CustomSeal Kit |
| Catalog Number | TV-CS14-G |
| 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
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
| Total Volume | 14 Milliliter |
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 | M701TVCS14G1 [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 | 2014-10-07 |
On-Brand Devices [Ovation Prime Abdominal Stent Graft System]
| M701TVIL142280E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL1422140E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL1422120E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL1422100E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL141880E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL1418140E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL1418120E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL1418100E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL141680E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL1416140E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL1416120E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL1416100E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL141480E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL1414140E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL1414120E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL1414100E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL141280E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL1412140E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL1412100E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL141080E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL1410140E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL1410120E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVIL1410100E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVFP14E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVEX222245E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVEX181845E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVEX161645E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVEX141445E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVEX121245E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVEX101045E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVCS14G1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVAI01E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVAB3480E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVAB2980E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVAB2380E1 | The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device deliver |
| M701TVAB2080E1 | The 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 85832445 4449077 Live/Registered |
TriVascular, Inc. 2013-01-25 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.