Ovation iX Iliac Stent Graft TV-IL1414160-J

GUDID 00850007370435

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.

Endologix, Inc.

Abdominal aorta endovascular stent-graft

• Primary Device ID: 00850007370435
• NIH Device Record Key: f867ca5f-4b0f-4875-a6f7-dd2c7c0585a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ovation iX Iliac Stent Graft
• Version Model Number: TV-IL1414160-J
• Catalog Number: TV-IL1414160-J
• Company DUNS: 179593652
• Company Name: Endologix, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com

Device Dimensions

• Stent Diameter: 14 Millimeter
• Catheter Gauge: 60 French
• Outer Diameter: 12 Femtometer
• Lumen/Inner Diameter: 10 Femtometer
• Stent Length: 160 Millimeter
• Stent Diameter: 14 Millimeter
• Catheter Gauge: 60 French
• Outer Diameter: 12 Femtometer
• Lumen/Inner Diameter: 10 Femtometer
• Stent Length: 160 Millimeter
• Stent Diameter: 14 Millimeter
• Catheter Gauge: 60 French
• Outer Diameter: 12 Femtometer
• Lumen/Inner Diameter: 10 Femtometer
• Stent Length: 160 Millimeter
• Stent Diameter: 14 Millimeter
• Catheter Gauge: 60 French
• Outer Diameter: 12 Femtometer
• Lumen/Inner Diameter: 10 Femtometer
• Stent Length: 160 Millimeter
• Stent Diameter: 14 Millimeter
• Catheter Gauge: 60 French
• Outer Diameter: 12 Femtometer
• Lumen/Inner Diameter: 10 Femtometer
• Stent Length: 160 Millimeter
• Stent Diameter: 14 Millimeter
• Catheter Gauge: 60 French
• Outer Diameter: 12 Femtometer
• Lumen/Inner Diameter: 10 Femtometer
• Stent Length: 160 Millimeter
• Stent Diameter: 14 Millimeter
• Catheter Gauge: 60 French
• Outer Diameter: 12 Femtometer
• Lumen/Inner Diameter: 10 Femtometer
• Stent Length: 160 Millimeter
• Stent Diameter: 14 Millimeter
• Catheter Gauge: 60 French
• Outer Diameter: 12 Femtometer
• Lumen/Inner Diameter: 10 Femtometer
• Stent Length: 160 Millimeter
• Stent Diameter: 14 Millimeter
• Catheter Gauge: 60 French
• Outer Diameter: 12 Femtometer
• Lumen/Inner Diameter: 10 Femtometer
• Stent Length: 160 Millimeter
• Stent Diameter: 14 Millimeter
• Catheter Gauge: 60 French
• Outer Diameter: 12 Femtometer
• Lumen/Inner Diameter: 10 Femtometer
• Stent Length: 160 Millimeter
• Stent Diameter: 14 Millimeter
• Catheter Gauge: 60 French
• Outer Diameter: 12 Femtometer
• Lumen/Inner Diameter: 10 Femtometer
• Stent Length: 160 Millimeter
• Stent Diameter: 14 Millimeter
• Catheter Gauge: 60 French
• Outer Diameter: 12 Femtometer
• Lumen/Inner Diameter: 10 Femtometer
• Stent Length: 160 Millimeter
• Stent Diameter: 14 Millimeter
• Catheter Gauge: 60 French
• Outer Diameter: 12 Femtometer
• Lumen/Inner Diameter: 10 Femtometer
• Stent Length: 160 Millimeter
• Stent Diameter: 14 Millimeter
• Catheter Gauge: 60 French
• Outer Diameter: 12 Femtometer
• Lumen/Inner Diameter: 10 Femtometer
• Stent Length: 160 Millimeter
• Stent Diameter: 14 Millimeter
• Catheter Gauge: 60 French
• Outer Diameter: 12 Femtometer
• Lumen/Inner Diameter: 10 Femtometer
• Stent Length: 160 Millimeter
• Stent Diameter: 14 Millimeter
• Catheter Gauge: 60 French
• Outer Diameter: 12 Femtometer
• Lumen/Inner Diameter: 10 Femtometer
• Stent Length: 160 Millimeter
• Stent Diameter: 14 Millimeter
• Catheter Gauge: 60 French
• Outer Diameter: 12 Femtometer
• Lumen/Inner Diameter: 10 Femtometer
• Stent Length: 160 Millimeter
• Stent Diameter: 14 Millimeter
• Catheter Gauge: 60 French
• Outer Diameter: 12 Femtometer
• Lumen/Inner Diameter: 10 Femtometer
• Stent Length: 160 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850007370435 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P120006

FDA Product Code

• MIH: System, Endovascular Graft, Aortic Aneurysm Treatment

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-10
• Device Publish Date: 2023-03-02

On-Brand Devices [Ovation iX Iliac Stent Graft]

• 00850007370060: The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™
• 00850007370053: The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™
• 00850007370046: The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™
• 00850007370039: The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™
• 00850007370015: "The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™
• 00085000737002: The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™
• 00850007370992: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370442: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370435: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370374: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370367: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370350: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370343: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370336: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370329: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370312: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370305: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370299: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370282: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370275: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370268: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370251: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370244: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370237: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370220: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370206: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370190: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370145: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370138: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370121: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370114: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370107: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370091: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370077: The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™
• 00850007370008: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370428: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370411: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370213: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370183: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370176: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370169: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370152: The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
• 00850007370022: The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™