Ovation iX Iliac Stent Graft

Basic Information

• Brand Name: Ovation iX Iliac Stent Graft
• Primary DI: 00850007370992
• Version / Model: TV-IL141080-J
• Catalog Number: TV-IL141080-J
• Company Name: Endologix, Inc.
• Labeler DUNS: 179593652
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-02
• Public Version: 1
• Public Version Date: 2023-03-10
• Public Version Status: New
• Public Device Record Key: 1d9445bf-82aa-4c2b-be79-8e808d9ba5c4

Device 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.

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	00850007370992	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P120006	001

Device Sizes

Type	Value	Unit	Text
Stent Diameter	14	Millimeter
Stent Diameter	10	Millimeter
Catheter Working Length	60	Centimeter
Outer Diameter	12	Femtometer
Lumen/Inner Diameter	10	Femtometer
Stent Length	80	Millimeter

Storage Conditions

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