DEVICE: Ovation iX Iliac Stent Graft (00850007370022)
Device Identifier (DI) Information
Ovation iX Iliac Stent Graft
TV-EX121245-J
In Commercial Distribution
TV-EX121245-J
Endologix, Inc.
TV-EX121245-J
In Commercial Distribution
TV-EX121245-J
Endologix, Inc.
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.
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
46777 | 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) [includes aortoiliac aneurysm]; it does not contain anticoagulants or pharmaceuticals. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is typically made of a metallic outer mesh structure with an inner polymer tube (endovascular graft) and is typically available as a: 1) single tube for insertion into the aorta and/or one iliac artery; or 2) two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MIH | System, Endovascular Graft, Aortic Aneurysm Treatment |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P120006 | 001 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in a cool, dry place. |
Clinically Relevant Size
[?]Size Type Text |
---|
Stent Diameter: 12 Millimeter |
Catheter Working Length: 60 Centimeter |
Outer Diameter: 12 Femtometer |
Lumen/Inner Diameter: 10 Femtometer |
Stent Length: 45 Millimeter |
Device Record Status
2aab954a-87ae-42b1-a363-d6e32d33e202
December 11, 2024
3
February 28, 2023
December 11, 2024
3
February 28, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(949) 595-7200
CustomerService@endologix.com
CustomerService@endologix.com