Ovation iX Iliac Stent Graft

Basic Information

• Brand Name: Ovation iX Iliac Stent Graft
• Primary DI: 00850007370022
• Version / Model: TV-EX121245-J
• Catalog Number: TV-EX121245-J
• Company Name: Endologix, Inc.
• Labeler DUNS: 179593652
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-28
• Public Version: 2
• Public Version Date: 2023-07-19
• Public Version Status: Update
• Public Device Record Key: 2aab954a-87ae-42b1-a363-d6e32d33e202

Device 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
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); it does not contain anticoagulants or pharmaceuticals that prevent narrowing of the vessels. 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 in two designs: 1) a single tube for insertion into one iliac artery; or 2) a two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850007370022	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P120006	001

Device Sizes

Type	Value	Unit	Text
Stent Diameter	12	Millimeter
Catheter Working Length	60	Centimeter
Outer Diameter	12	Femtometer
Lumen/Inner Diameter	10	Femtometer
Stent Length	45	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place.