Alto™ Abdominal Stent Graft System
Basic Information
- Brand Name
- Alto™ Abdominal Stent Graft System
- Primary DI
- M701TVAB2680N1
- Version / Model
- TV-AB2680-N
- Catalog Number
- TV-AB2680-N
- Company Name
- Endologix, Inc.
- Labeler DUNS
- 179593652
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-04
- Public Version
- 6
- Public Version Date
- 2023-02-23
- Public Version Status
- Update
- Public Device Record Key
- c516a36c-bb98-4513-b01f-b382e40920cd
Device 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.
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
- Yes
- 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 | M701TVAB2680N1 | HIBCC |
Customer Contacts
- Phone
- (949) 595-7200
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P120006 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Stent Graft Proximal Diameter | ||
| Device Size Text, specify | Catheter Working Length | ||
| Device Size Text, specify | Delivery System Outer Profile | ||
| Device Size Text, specify | Integral Sheath Inner Diameter | ||
| Device Size Text, specify | Covered Stent Graft Length |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry.