FDA.report

GORE TAG Conformable Thoracic Stent Graft

Primary DI
00733132661695
Company
W. L. Gore & Associates, Inc.
Model
TGMR403415
Catalog number
TGMR403415
Device description
CTAG CMDS 40MMX34MMX15CM 22Fr
Published
2025-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
967358115
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00733132661695PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00733132661695PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
MIHSystem, Endovascular Graft, Aortic Aneurysm Treatment3UnknownYIneligible

Premarket Submissions

SubmissionSupplement
P040043140

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
P040043140GORE TAG THORACIC ENDOPROSTHESISW. L. GORE & ASSOCIATES, INC.2005-03-23MIH

GMDN Terms

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

TypeValueText
Catheter Gauge22 French
Lumen/Inner Diameter34 Millimeter
Lumen/Inner Diameter40 Millimeter

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

PhoneEmail
800-528-8763mpdcustomercare@wlgore.com

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00733132663736GORE® VIABAHN® FORTEGRA Venous StentVNS280502AVNS280502A2026-01-08
00733132663743GORE® VIABAHN® FORTEGRA Venous StentVNS241502AVNS241502A2026-01-08
00733132663750GORE® VIABAHN® FORTEGRA Venous StentVNS241002AVNS241002A2026-01-08
00733132663767GORE® VIABAHN® FORTEGRA Venous StentVNS240502AVNS240502A2026-01-08
00733132663774GORE® VIABAHN® FORTEGRA Venous StentVNS201502AVNS201502A2026-01-08
00733132663781GORE® VIABAHN® FORTEGRA Venous StentVNS201002AVNS201002A2026-01-08
00733132663798GORE® VIABAHN® FORTEGRA Venous StentVNS200702AVNS200702A2026-01-08
00733132663804GORE® VIABAHN® FORTEGRA Venous StentVNS200502AVNS200502A2026-01-08
00733132663811GORE® VIABAHN® FORTEGRA Venous StentVNS181502AVNS181502A2026-01-08
00733132663828GORE® VIABAHN® FORTEGRA Venous StentVNS181002AVNS181002A2026-01-08
00733132663835GORE® VIABAHN® FORTEGRA Venous StentVNS180702AVNS180702A2026-01-08
00733132663842GORE® VIABAHN® FORTEGRA Venous StentVNS180502AVNS180502A2026-01-08
00733132663859GORE® VIABAHN® FORTEGRA Venous StentVNS161502AVNS161502A2026-01-08
00733132663866GORE® VIABAHN® FORTEGRA Venous StentVNS161002AVNS161002A2026-01-08
00733132663873GORE® VIABAHN® FORTEGRA Venous StentVNS160702AVNS160702A2026-01-08

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