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
00843576150416RelayPro NBS Thoracic Stent-Graft System28-N4-22-099-22U28-N4-22-099-22U2023-04-24
00843576150546RelayPro NBS Thoracic Stent-Graft System28-N4-22-159-22U28-N4-22-159-22U2023-04-24
00843576150676RelayPro NBS Thoracic Stent-Graft System28-N4-22-199-22U28-N4-22-199-22U2023-04-24
00843576150805RelayPro NBS Thoracic Stent-Graft System28-N4-22-259-22U28-N4-22-259-22U2023-04-24
00843576150874RelayPro Thoracic Stent-Graft System28-N4-36-259-36U28-N4-36-259-36U2021-09-23
00843576150218RelayPro Thoracic Stent-Graft System28-M4-28-195-24U28-M4-28-195-24U2021-09-22
00843576150225RelayPro Thoracic Stent-Graft System28-M4-30-200-26U28-M4-30-200-26U2021-09-22
00843576150232RelayPro Thoracic Stent-Graft System28-M4-32-200-28U28-M4-32-200-28U2021-09-22
00843576150249RelayPro Thoracic Stent-Graft System28-M4-34-200-30U28-M4-34-200-30U2021-09-22
00843576150256RelayPro Thoracic Stent-Graft System28-M4-36-190-32U28-M4-36-190-32U2021-09-22
00843576150263RelayPro Thoracic Stent-Graft System28-M4-38-190-34U28-M4-38-190-34U2021-09-22
00843576150270RelayPro Thoracic Stent-Graft System28-M4-40-195-36U28-M4-40-195-36U2021-09-22
00843576150287RelayPro Thoracic Stent-Graft System28-M4-42-195-38U28-M4-42-195-38U2021-09-22
00843576150294RelayPro Thoracic Stent-Graft System28-M4-44-200-40U28-M4-44-200-40U2021-09-22
00843576150300RelayPro Thoracic Stent-Graft System28-M4-46-200-42U28-M4-46-200-42U2021-09-22
00843576150317RelayPro Thoracic Stent-Graft System28-M4-28-250-24U28-M4-28-250-24U2021-09-22
00843576150324RelayPro Thoracic Stent-Graft System28-M4-30-250-26U28-M4-30-250-26U2021-09-22
00843576150331RelayPro Thoracic Stent-Graft System28-M4-32-250-28U28-M4-32-250-28U2021-09-22
00843576150348RelayPro Thoracic Stent-Graft System28-M4-34-250-30U28-M4-34-250-30U2021-09-22
00843576150355RelayPro Thoracic Stent-Graft System28-M4-36-250-32U28-M4-36-250-32U2021-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827002599819Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599840Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599871Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599901Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599932Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599963Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599994Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600027Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600058Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600089Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600119Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600140Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600171Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600201Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600232Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600263Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600294Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600324Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600355Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600393Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600409Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600430Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600461Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600492Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600522Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600553Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600584Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600614Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600645Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600676Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04