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.
00850007370022
GS1

1
179593652 *Terms of Use
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.
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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
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FDA Product Code

[?]
Product Code Product Code Name
MIH System, Endovascular Graft, Aortic Aneurysm Treatment
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P120006 001
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a cool, dry place.
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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
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Device Record Status

2aab954a-87ae-42b1-a363-d6e32d33e202
December 11, 2024
3
February 28, 2023
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
(949) 595-7200
CustomerService@endologix.com
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