DEVICE: TREO Abdominal Stent-Graft System (08435761052098)
Device Identifier (DI) Information
TREO Abdominal Stent-Graft System
28-L2-20-100U
Not in Commercial Distribution
28-L2-20-100U
Bolton Medical Inc.
28-L2-20-100U
Not in Commercial Distribution
28-L2-20-100U
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 | 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) [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 typically made of a metallic outer mesh structure with an inner 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.
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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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 5 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 15 Millimeter |
Outer Diameter: 20 Millimeter |
Length: 100 Millimeter |
Catheter Gauge: 14 French |
Device Record Status
8cf7577d-658e-47a7-affc-d515ab5c81c7
December 11, 2024
8
May 19, 2020
December 11, 2024
8
May 19, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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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