FDA.reportPublic FDA data

RelayPro Thoracic Stent-Graft System

Primary DI
00843576171923
Brand
RelayPro Thoracic Stent-Graft System
Company
Bolton Medical Inc.
Model
28-N4-38-110-44U
Catalog number
28-N4-38-110-44U
Device description
Endovascular Stent-Graft System
Published
2022-05-03
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
P200045000
P200045001
P200045002
P200045003

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200045000RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH
P200045001RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH
P200045002RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH
P200045003RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843576171923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843576171923008435761719238435761719230843576171923

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 Gauge23French
Length108Millimeter
Length110Millimeter
Outer Diameter38Millimeter
Outer Diameter44Millimeter

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
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