FDA.reportPublic FDA data

TREO Abdominal Stent-Graft System

Primary DI
00843576152700
Brand
TREO Abdominal Stent-Graft System
Company
Bolton Medical Inc.
Model
28-C2-33-055U
Catalog number
28-C2-33-055U
Device description
Endovascular Stent-Graft System
Published
2021-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MIHSystem, Endovascular Graft, Aortic Aneurysm Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIHSystem, Endovascular Graft, Aortic Aneurysm TreatmentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P190015000
P190015001
P190015002
P190015003
P190015004
P190015005
P190015006
P190015007
P190015008
P190015009
P190015010
P190015012
P190015013
P190015014
P190015016
P190015017
P190015018
P190015019
P190015020
P190015021
P190015022
P190015023
P190015024
P190015025
P190015026
P190015027
P190015029

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190015000TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015001TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015002TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015003TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015004TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015005TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015006TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015007TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015008TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015009TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015010TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015012TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015013TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015014TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015016TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015017TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015018TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015019TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015020TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015021TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015022TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015023TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015024TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015025TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015026TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015027TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH
P190015029TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.2020-05-04MIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843576152700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843576152700008435761527008435761527000843576152700

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal aorta endovascular stent-graftA 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 is percutaneously inserted via the femoral artery to the site of implantation, with a disposable delivery device, where it self-expands. It is typically made of nickel-titanium alloy (Nitinol) that forms an outer mesh structure with an inner polymer tube (endovascular graft). It is typically available in two designs: 1) a single continuous tube for insertion into one iliac artery; or 2) a two-part bifurcation design (e.g., shaped as a Y in a tube form) for insertion through both iliac arteries.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge19French
Length55Millimeter
Outer Diameter33Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
847424462
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843576152458TREO Abdominal Stent-Graft System 28-B2-30-100U28-B2-30-100U2021-02-02
00843576152625TREO Abdominal Stent-Graft System 28-C2-33-040U28-C2-33-040U2021-02-02
00843576152632TREO Abdominal Stent-Graft System 28-C2-36-040U28-C2-36-040U2021-02-02
00843576152649TREO Abdominal Stent-Graft System 28-C2-20-055U28-C2-20-055U2021-02-02
00843576152656TREO Abdominal Stent-Graft System 28-C2-22-055U28-C2-22-055U2021-02-02
00843576152663TREO Abdominal Stent-Graft System 28-C2-24-055U28-C2-24-055U2021-02-02
00843576152670TREO Abdominal Stent-Graft System 28-C2-26-055U28-C2-26-055U2021-02-02
00843576152687TREO Abdominal Stent-Graft System 28-C2-28-055U28-C2-28-055U2021-02-02
00843576152694TREO Abdominal Stent-Graft System 28-C2-30-055U28-C2-30-055U2021-02-02
00843576152717TREO Abdominal Stent-Graft System 28-C2-36-055U28-C2-36-055U2021-02-02
00843576152724TREO Abdominal Stent-Graft System 28-C2-20-070U28-C2-20-070U2021-02-02
00843576152731TREO Abdominal Stent-Graft System 28-C2-22-070U28-C2-22-070U2021-02-02
00843576152748TREO Abdominal Stent-Graft System 28-C2-24-070U28-C2-24-070U2021-02-02
00843576152755TREO Abdominal Stent-Graft System 28-C2-26-070U28-C2-26-070U2021-02-02
00843576152762TREO Abdominal Stent-Graft System 28-C2-28-070U28-C2-28-070U2021-02-02
00843576152779TREO Abdominal Stent-Graft System 28-C2-30-070U28-C2-30-070U2021-02-02
00843576152786TREO Abdominal Stent-Graft System 28-C2-33-070U28-C2-33-070U2021-02-02
00843576152793TREO Abdominal Stent-Graft System 28-C2-36-070U28-C2-36-070U2021-02-02
08435761052456TREO Abdominal Stent-Graft System 28-B2-30-100U28-B2-30-100U2020-05-19
08435761052562TREO Abdominal Stent-Graft System 28-C2-20-040U28-C2-20-040U2020-05-19

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Primary DI, Brand, Company table
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00733132667000GORE® TAG® Thoracic Branch EndoprosthesisW. L. Gore & Associates, Inc.MIH2026-05-26
00733132667017GORE® TAG® Thoracic Branch EndoprosthesisW. L. Gore & Associates, Inc.MIH2026-05-26
00733132667024GORE® TAG® Thoracic Branch EndoprosthesisW. L. Gore & Associates, Inc.MIH2026-05-26
00827002603400COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
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00827002603424COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
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00827002603448COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00827002603455COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00827002603462COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00827002603479COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603407COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603414COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603421COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603438COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603445COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
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10827002603469COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603476COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
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