FDA.reportPublic FDA data

Relay Plus Thoracic Stent-Graft System

Primary DI
00843576102415
Brand
Relay Plus Thoracic Stent-Graft System
Company
Bolton Medical Inc.
Model
28-M338250342590U
Catalog number
28-M338250342590U
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
P110038000
P110038001
P110038002
P110038004
P110038005
P110038006
P110038008
P110038009
P110038010
P110038011
P110038012
P110038013
P110038014
P110038015
P110038016
P110038017
P110038018
P110038021
P110038022
P110038023
P110038024
P110038025
P110038026
P110038027
P110038029
P110038030
P110038031
P110038032

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P110038000RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038001RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038002RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038004RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038005RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038006RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038008RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038009RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038010RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038011RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038012RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038013RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038014RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038015RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038016RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038017RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038018RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038021RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038022RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038023RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038024RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038025RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038026RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038027RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038029RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038030RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038031RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH
P110038032RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEMBolton Medical, Inc.2012-09-21MIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843576102415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843576102415008435761024158435761024150843576102415

GMDN Terms#

Term, Definition table
TermDefinition
Descending thoracic aorta endovascular stent-graftA non-bioabsorbable tubular device intended to be implanted within the descending thoracic aorta to repair the vessel [includes repair of thoracic aortic aneurysm (TAA), traumatic transsections/dissections, fistulae, penetrating ulcers]. It is typically made of a metal alloy [e.g., nickel-titanium alloy (Nitinol)] that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft) and is typically designed as a single continuous tube which may be used in singular and/or modular configurations. It is intended for percutaneous introduction; disposable delivery device (e.g., balloon catheter) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge25French
Length250Millimeter
Outer Diameter34Millimeter
Outer Diameter38Millimeter

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
Manufacturing date on label
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
00843576152700TREO Abdominal Stent-Graft System 28-C2-33-055U28-C2-33-055U2021-02-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00733132666980GORE® TAG® Thoracic Branch EndoprosthesisW. L. Gore & Associates, Inc.MIH2026-05-26
00733132666997GORE® TAG® Thoracic Branch EndoprosthesisW. L. Gore & Associates, Inc.MIH2026-05-26
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
00827002603417COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00827002603424COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00827002603431COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
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
10827002603452COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603469COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603476COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00733132661664GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.MIH2025-03-18
00733132661671GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.MIH2025-03-18
00733132661688GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.MIH2025-03-18
00733132661695GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.MIH2025-03-18
00827002601598Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
00827002601659Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
00827002601710Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
00827002601741Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
00827002601772Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18