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Alto™ Abdominal Stent Graft System

FDA UDI

Class III (US FDA UDI)

by Endologix LLC

Identity

Trade Name
Alto™ Abdominal Stent Graft System FDA UDI
Generic Name
Aortoiliac endovascular stent-graft FDA UDI
Device Name
"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." FDA UDI
Model / Reference
TV-AB3480-N FDA UDI
Description
"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." FDA UDI

Identifiers

Catalog Number
TV-AB3480-N FDA UDI
Primary DI / UDI-DI
00850007370916 FDA UDI
PMA Number
P120006 FDA UDI
FDA Product Code
MIH FDA UDI
GMDN Term
Aortoiliac endovascular stent-graft FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Stent Diameter — 34 Millimeter FDA UDI
Catheter Working Length — 60 Centimeter FDA UDI
Outer Diameter — 15 Femtometer FDA UDI
Lumen/Inner Diameter — 13 Femtometer FDA UDI
Shaft Length — 80 Millimeter FDA UDI

Category: Aortoiliac endovascular stent-graft

Alto™ Abdominal Stent Graft System by Endologix LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Aortoiliac endovascular stent-graft.

Cleared under the same submission

P120006 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Endologix LLC

Sources (1)

  • FDA UDI eebc1f31-2c5c-40a5-9870-0d26bed40d10 38 fields · synced Jun 1, 2026