FDA.reportPublic FDA data

Aorfix AAA Stent Graft Body with Aorflex Delivery System

Primary DI
05055715606578
Brand
Aorfix AAA Stent Graft Body with Aorflex Delivery System
Company
LOMBARD MEDICAL LIMITED
Model
SG-HBB-24-111-97-16-A12-22
Device description
Aorflex AAA Stent Graft Body with Aorflex Delivery System
Published
2015-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
P110032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P110032000AORFIX FLEXIBLE STENT GRAFT SYSTEMLombard Medical Limited2013-02-14MIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055715606578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055715606578050557156065785055715606578

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal aorta endovascular stent-graftA sterile non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA). It is percutaneously inserted via the femoral artery to the site of implantation, with a disposable delivery device, where it self-expands. It is typically made of nickel-titanium alloy (Nitinol) that forms an outer mesh structure with an inner polymer tube (endovascular graft). It is typically available in two designs: 1) a single continuous tube for insertion into one iliac artery; or 2) a two-part bifurcation design (e.g., shaped as a Y in a tube form) for insertion through both iliac arteries.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+44 1235750800kirsty.cook@lombardmedical.com

Regulatory Flags#

DUNS number
775481088
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055715606424Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-63-10-A12-222015-04-28
05055715606431Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-63-12-A12-222015-04-29
05055715606448Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-63-14-A12-222015-04-29
05055715606455Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-63-16-A12-222015-04-29
05055715606462Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-63-18-A12-222015-04-29
05055715606479Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-63-20-A12-222015-04-29
05055715606486Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-80-10-A12-222015-04-29
05055715606493Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-80-12-A12-222015-04-29
05055715606509Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-80-14-A12-222015-04-29
05055715606516Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-80-16-A12-222015-04-29
05055715606523Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-80-18-A12-222015-04-29
05055715606530Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-80-20-A12-222015-04-29
05055715606547Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-97-10-A12-222015-04-29
05055715606554Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-97-12-A12-222015-04-29
05055715606561Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-97-14-A12-222015-04-29
05055715606585Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-97-18-A12-222015-04-29
05055715606592Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-111-97-20-A12-222015-04-29
05055715606608Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-126-63-10-A12-222015-04-29
05055715606615Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-126-63-12-A12-222015-04-29
05055715606622Aorfix AAA Stent Graft Body with Aorflex Delivery SystemSG-HBB-24-126-63-14-A12-222015-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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