DEVICE: TREO Abdominal Stent-Graft System (00843576152267)
Device Identifier (DI) Information
TREO Abdominal Stent-Graft System
28-L2-11-160U
In Commercial Distribution
28-L2-11-160U
Bolton Medical Inc.
28-L2-11-160U
In Commercial Distribution
28-L2-11-160U
Bolton Medical Inc.
Endovascular Stent-Graft System
Device Characteristics
| MR Conditional | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 46777 | Aortoiliac 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) [includes aortoiliac aneurysm]; it does not contain anticoagulants or pharmaceuticals. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is made of a metallic mesh structure with a polymer tube (endovascular graft) and is typically available as a: 1) single tube for insertion into the aorta and/or one iliac artery; or 2) two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries.
|
Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| P190015 | 000 |
| P190015 | 001 |
| P190015 | 002 |
| P190015 | 003 |
| P190015 | 004 |
| P190015 | 005 |
| P190015 | 006 |
| P190015 | 007 |
| P190015 | 008 |
| P190015 | 009 |
| P190015 | 010 |
| P190015 | 012 |
| P190015 | 013 |
| P190015 | 014 |
| P190015 | 017 |
| P190015 | 018 |
| P190015 | 019 |
| P190015 | 020 |
| P190015 | 021 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 5 and 40 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Outer Diameter: 15 Millimeter |
| Outer Diameter: 11 Millimeter |
| Length: 161 Millimeter |
| Catheter Gauge: 13 French |
Device Record Status
16078430-9566-4264-821b-dc694d48b1e7
September 24, 2025
8
February 02, 2021
September 24, 2025
8
February 02, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined