FDA.reportPublic FDA data

RelayPro Thoracic Stent-Graft System

Primary DI
00843576155282
Brand
RelayPro Thoracic Stent-Graft System
Company
Bolton Medical Inc.
Model
28-M4-28-250-22U
Catalog number
28-M4-28-250-22U
Device description
Endovascular Stent-Graft System
Published
2023-04-25
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
P200045002
P200045005
P200045008
P200045009
P200045010
P200045011
P200045012
P200045013
P200045014

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200045002RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH
P200045005RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH
P200045008RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH
P200045009RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH
P200045010RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH
P200045011RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH
P200045012RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH
P200045013RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH
P200045014RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843576155282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843576155282008435761552828435761552820843576155282

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 Gauge19French
Length250Millimeter
Outer Diameter22Millimeter
Outer Diameter28Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling 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