Identity
- Trade Name
- Ovation iX Iliac Stent Graft FDA UDI
- Generic Name
- Aortoiliac endovascular stent-graft FDA UDI
- Device Name
- "The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Extensions are comprised of a nitinol stent encapsulated in low-permeability PTFE. Iliac extensions may be used to extend the length of the device, where indicated." FDA UDI
- Model / Reference
- TV-EX101045-J FDA UDI
- Description
- "The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Extensions are comprised of a nitinol stent encapsulated in low-permeability PTFE. Iliac extensions may be used to extend the length of the device, where indicated." FDA UDI
Identifiers
- Catalog Number
- TV-EX101045-J FDA UDI
- Primary DI / UDI-DI
- 00850007370015 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 — 10 Millimeter FDA UDICatheter Working Length — 60 Centimeter FDA UDIOuter Diameter — 12 Femtometer FDA UDILumen/Inner Diameter — 10 Femtometer FDA UDIStent Length — 45 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 87745c3a-2fb5-4c73-92e4-aa86de91d509 38 fields · synced May 31, 2026