TREO Abdominal Stent-Graft System

Basic Information

• Brand Name: TREO Abdominal Stent-Graft System
• Primary DI: 08435761052678
• Version / Model: 28-C2-26-055U
• Catalog Number: 28-C2-26-055U
• Company Name: Bolton Medical Inc.
• Labeler DUNS: 847424462
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-19
• Public Version: 7
• Public Version Date: 2023-09-22
• Public Version Status: Update
• Public Device Record Key: d8e2748f-ca45-4d33-9912-0ef67417a18c
• Distribution End Date: 2023-05-19

Device Description

Endovascular Stent-Graft System

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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	08435761052678	GS1

Premarket Submissions

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	26	Millimeter
Length	55	Millimeter
Catheter Gauge	18	French

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius