Identity
- Trade Name
- Ovation iX Iliac Stent Graft FDA UDI
- Generic Name
- Aortoiliac endovascular stent-graft FDA UDI
- Device Name
- The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Limbs are comprised of a nitinol stent encapsulated in low-permeability PTFE. The iliac limbs are deployed into the leg sections of the aortic body. Additional iliac limbs may be used to extend the length of the device, where indicated. FDA UDI
- Model / Reference
- TV-IL1428140-J FDA UDI
- Description
- The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Limbs are comprised of a nitinol stent encapsulated in low-permeability PTFE. The iliac limbs are deployed into the leg sections of the aortic body. Additional iliac limbs may be used to extend the length of the device, where indicated. FDA UDI
Identifiers
- Catalog Number
- TV-IL1428140-J FDA UDI
- Primary DI / UDI-DI
- 00850007370091 FDA UDI
- PMA Number
- P120006 FDA UDI
- FDA Product Code
- MIH FDA UDI
- GMDN Term
- Aortoiliac endovascular stent-graft FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Stent Diameter — 14 Millimeter FDA UDIStent Diameter — 28 Millimeter FDA UDICatheter Working Length — 60 Centimeter FDA UDIOuter Diameter — 15 Femtometer FDA UDILumen/Inner Diameter — 13 Femtometer FDA UDIStent Length — 140 Millimeter FDA UDI
Category: Aortoiliac endovascular stent-graft
Ovation iX Iliac Stent Graft by Endologix LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aortoiliac endovascular stent-graft.
- Aorfix AAA Stent Graft Body with Aorflex Delivery System — LOMBARD MEDICAL LIMITED · Class III
- TREO Abdominal Stent-Graft System — Bolton Medical Inc. · Class III
- Endurant® II — MEDTRONIC, INC. · Class III
- Zenith Spiral-Z — COOK INCORPORATED · Class III
- Zenith Renu — COOK INCORPORATED · Class III
- Endurant® II — MEDTRONIC, INC. · Class III
- Aorfix AAA Stent Graft Body with Aorflex Delivery System — LOMBARD MEDICAL LIMITED · Class III
- Zenith Renu — COOK INCORPORATED · Class III
Cleared under the same submission
P120006 also covers:
- Alto™ Abdominal Stent Graft System — Endologix LLC
- Alto™ Abdominal Stent Graft System — Endologix LLC
- Alto™ Abdominal Stent Graft System — Endologix LLC
- Alto™ Abdominal Stent Graft System — Endologix LLC
- Autoinjector 2 — Endologix LLC
- Ovation Prime Abdominal Stent Graft System — Endologix LLC
- Ovation iX Iliac Stent Graft — Endologix LLC
- Ovation iX Iliac Stent Graft — Endologix LLC
- Ovation iX Iliac Stent Graft — Endologix LLC
- Ovation iX Iliac Stent Graft — Endologix LLC
- Ovation iX Iliac Stent Graft — Endologix LLC
- Ovation iX Iliac Stent Graft — Endologix LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Endologix LLC
Sources (1)
- FDA UDI 2949ce2f-daeb-4de5-81f4-72d2d5ee9856 38 fields · synced May 30, 2026