Alto™ Abdominal Stent Graft System TV-AB2380-N

GUDID 00850007370886

"The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high-pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required. The Alto™ Abdominal Stent Graft System includes: an Aortic Body Stent Graft and delivery catheter, Ovation iX™ Iliac Limb Stent Grafts and delivery catheters, Ovation iX™ Iliac Extension Stent Grafts and delivery catheters (as required), the CustomSeal™ Polymer Fill Kit, and the Autoinjector 2."

Endologix, Inc.

Abdominal aorta endovascular stent-graft

• Primary Device ID: 00850007370886
• NIH Device Record Key: aec1710c-e802-419e-95f9-4325768cbe03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alto™ Abdominal Stent Graft System
• Version Model Number: TV-AB2380-N
• Catalog Number: TV-AB2380-N
• 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: 23 Millimeter
• Catheter Working Length: 60 Centimeter
• Outer Diameter: 15 Femtometer
• Stent Length: 80 Millimeter
• Lumen/Inner Diameter: 13 Femtometer
• Stent Diameter: 23 Millimeter
• Catheter Working Length: 60 Centimeter
• Outer Diameter: 15 Femtometer
• Stent Length: 80 Millimeter
• Lumen/Inner Diameter: 13 Femtometer
• Stent Diameter: 23 Millimeter
• Catheter Working Length: 60 Centimeter
• Outer Diameter: 15 Femtometer
• Stent Length: 80 Millimeter
• Lumen/Inner Diameter: 13 Femtometer
• Stent Diameter: 23 Millimeter
• Catheter Working Length: 60 Centimeter
• Outer Diameter: 15 Femtometer
• Stent Length: 80 Millimeter
• Lumen/Inner Diameter: 13 Femtometer
• Stent Diameter: 23 Millimeter
• Catheter Working Length: 60 Centimeter
• Outer Diameter: 15 Femtometer
• Stent Length: 80 Millimeter
• Lumen/Inner Diameter: 13 Femtometer
• Stent Diameter: 23 Millimeter
• Catheter Working Length: 60 Centimeter
• Outer Diameter: 15 Femtometer
• Stent Length: 80 Millimeter
• Lumen/Inner Diameter: 13 Femtometer
• Stent Diameter: 23 Millimeter
• Catheter Working Length: 60 Centimeter
• Outer Diameter: 15 Femtometer
• Stent Length: 80 Millimeter
• Lumen/Inner Diameter: 13 Femtometer
• Stent Diameter: 23 Millimeter
• Catheter Working Length: 60 Centimeter
• Outer Diameter: 15 Femtometer
• Stent Length: 80 Millimeter
• Lumen/Inner Diameter: 13 Femtometer
• Stent Diameter: 23 Millimeter
• Catheter Working Length: 60 Centimeter
• Outer Diameter: 15 Femtometer
• Stent Length: 80 Millimeter
• Lumen/Inner Diameter: 13 Femtometer
• Stent Diameter: 23 Millimeter
• Catheter Working Length: 60 Centimeter
• Outer Diameter: 15 Femtometer
• Stent Length: 80 Millimeter
• Lumen/Inner Diameter: 13 Femtometer
• Stent Diameter: 23 Millimeter
• Catheter Working Length: 60 Centimeter
• Outer Diameter: 15 Femtometer
• Stent Length: 80 Millimeter
• Lumen/Inner Diameter: 13 Femtometer
• Stent Diameter: 23 Millimeter
• Catheter Working Length: 60 Centimeter
• Outer Diameter: 15 Femtometer
• Stent Length: 80 Millimeter
• Lumen/Inner Diameter: 13 Femtometer
• Stent Diameter: 23 Millimeter
• Catheter Working Length: 60 Centimeter
• Outer Diameter: 15 Femtometer
• Stent Length: 80 Millimeter
• Lumen/Inner Diameter: 13 Femtometer
• Stent Diameter: 23 Millimeter
• Catheter Working Length: 60 Centimeter
• Outer Diameter: 15 Femtometer
• Stent Length: 80 Millimeter
• Lumen/Inner Diameter: 13 Femtometer
• Stent Diameter: 23 Millimeter
• Catheter Working Length: 60 Centimeter
• Outer Diameter: 15 Femtometer
• Stent Length: 80 Millimeter
• Lumen/Inner Diameter: 13 Femtometer
• Stent Diameter: 23 Millimeter
• Catheter Working Length: 60 Centimeter
• Outer Diameter: 15 Femtometer
• Stent Length: 80 Millimeter
• Lumen/Inner Diameter: 13 Femtometer
• Stent Diameter: 23 Millimeter
• Catheter Working Length: 60 Centimeter
• Outer Diameter: 15 Femtometer
• Stent Length: 80 Millimeter
• Lumen/Inner Diameter: 13 Femtometer
• Stent Diameter: 23 Millimeter
• Catheter Working Length: 60 Centimeter
• Outer Diameter: 15 Femtometer
• Stent Length: 80 Millimeter
• Lumen/Inner Diameter: 13 Femtometer

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850007370886 [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: 2023-03-08
• Device Publish Date: 2023-02-28

On-Brand Devices [Alto™ Abdominal Stent Graft System]

• M701TVAB3480N1: The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile c
• M701TVAB2980N1: The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile c
• M701TVAB2680N1: The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile c
• M701TVAB2380N1: The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile c
• M701TVAB2080N1: The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile c
• 00850007370916: "The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile
• 00850007370909: "The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile
• 00850007370893: "The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile
• 00850007370886: "The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile
• 00850007370381: "The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile