FDA.reportPublic FDA data

RelayPro Thoracic Stent-Graft System

Primary DI
00843576150300
Brand
RelayPro Thoracic Stent-Graft System
Company
Bolton Medical Inc.
Model
28-M4-46-200-42U
Catalog number
28-M4-46-200-42U
Device description
Endovascular Stent-Graft System
Published
2021-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
P200045005
P200045006
P200045008
P200045009
P200045010
P200045011
P200045012
P200045013
P200045014
P200045015
P200045016
P200045017
P200045018
P200045019
P200045020
P200045022
P200045024

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
P200045005RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH
P200045006RelayPro 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
P200045015RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH
P200045016RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH
P200045017RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH
P200045018RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH
P200045019RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH
P200045020RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH
P200045022RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH
P200045024RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.2021-08-05MIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843576150300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843576150300008435761503008435761503000843576150300

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 not intended for implantation within the aortic arch. 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 Gauge0
Length0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00

Regulatory Flags#

DUNS number
847424462
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00843576150362RelayPro Thoracic Stent-Graft System28-M4-38-250-34U28-M4-38-250-34U2021-09-22

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