FDA.reportPublic FDA data

AFX Endovascular AAA System

Primary DI
00818009014177
Brand
AFX Endovascular AAA System
Company
Endologix LLC
Model
BA28-40/I20-40
Published
2014-09-24
Public version status
Update
Distribution status
Not 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
P040002040
P040002041
P040002042
P040002043
P040002044
P040002045
P040002046
P040002047
P040002048
P040002050
P040002051
P040002052
P040002054
P040002056

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040002040ENDOLOGIX POWERLINK SYSTEMEndologix, LLC2004-10-29MIH
P040002041ENDOLOGIX POWERLINK SYSTEMEndologix, LLC2004-10-29MIH
P040002042ENDOLOGIX POWERLINK SYSTEMEndologix, LLC2004-10-29MIH
P040002043ENDOLOGIX POWERLINK SYSTEMEndologix, LLC2004-10-29MIH
P040002044ENDOLOGIX POWERLINK SYSTEMEndologix, LLC2004-10-29MIH
P040002045ENDOLOGIX POWERLINK SYSTEMEndologix, LLC2004-10-29MIH
P040002046ENDOLOGIX POWERLINK SYSTEMEndologix, LLC2004-10-29MIH
P040002047ENDOLOGIX POWERLINK SYSTEMEndologix, LLC2004-10-29MIH
P040002048ENDOLOGIX POWERLINK SYSTEMEndologix, LLC2004-10-29MIH
P040002050ENDOLOGIX POWERLINK SYSTEMEndologix, LLC2004-10-29MIH
P040002051ENDOLOGIX POWERLINK SYSTEMEndologix, LLC2004-10-29MIH
P040002052ENDOLOGIX POWERLINK SYSTEMEndologix, LLC2004-10-29MIH
P040002054ENDOLOGIX POWERLINK SYSTEMEndologix, LLC2004-10-29MIH
P040002056ENDOLOGIX POWERLINK SYSTEMEndologix, LLC2004-10-29MIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818009014177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818009014177008180090141778180090141770818009014177

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity40 Percent (%) Relative Humidity
Storage Environment Temperature46 Degrees Fahrenheit59 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(949) 595-7200CustomerService@endologix.com

Regulatory Flags#

DUNS number
858560477
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850007370152Ovation iX Iliac Stent GraftTV-IL141280-JTV-IL141280-J2023-03-03
00850007370169Ovation iX Iliac Stent GraftTV-IL1412100-JTV-IL1412100-J2023-03-03
00850007370176Ovation iX Iliac Stent GraftTV-IL1412120-JTV-IL1412120-J2023-03-03
00850007370183Ovation iX Iliac Stent GraftTV-IL1412140-JTV-IL1412140-J2023-03-03
00850007370213Ovation iX Iliac Stent GraftTV-IL1414120-JTV-IL1414120-J2023-03-03
00850007370411Ovation iX Iliac Stent GraftTV-IL1412160-JTV-IL1412160-J2023-03-03
00850007370428Ovation iX Iliac Stent GraftTV-IL1414100-JTV-IL1414100-J2023-03-03
00850007370091Ovation iX Iliac Stent GraftTV-IL1428140-JTV-IL1428140-J2023-03-02
00850007370107Ovation iX Iliac Stent GraftTV-IL141480-JTV-IL141480-J2023-03-02
00850007370114Ovation iX Iliac Stent GraftTV-IL1410160-JTV-IL1410160-J2023-03-02
00850007370190Ovation iX Iliac Stent GraftTV-IL1428120-JTV-IL1428120-J2023-03-02
00850007370206Ovation iX Iliac Stent GraftTV-IL1428100-JTV-IL1428100-J2023-03-02
00850007370220Ovation iX Iliac Stent GraftTV-IL1414140-JTV-IL1414140-J2023-03-02
00850007370237Ovation iX Iliac Stent GraftTV-IL141680-JTV-IL141680-J2023-03-02
00850007370244Ovation iX Iliac Stent GraftTV-IL1416100-JTV-IL1416100-J2023-03-02
00850007370251Ovation iX Iliac Stent GraftTV-IL1416120-JTV-IL1416120-J2023-03-02
00850007370268Ovation iX Iliac Stent GraftTV-IL1416140-JTV-IL1416140-J2023-03-02
00850007370275Ovation iX Iliac Stent GraftTV-IL141880-JTV-IL141880-J2023-03-02
00850007370282Ovation iX Iliac Stent GraftTV-IL1418100-JTV-IL1418100-J2023-03-02
00850007370299Ovation iX Iliac Stent GraftTV-IL1418120-JTV-IL1418120-J2023-03-02

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