DEVICE: Endurant® II (00643169467590)
Device Identifier (DI) Information
Endurant® II
ETLW1613C124E
In Commercial Distribution
MEDTRONIC, INC.
ETLW1613C124E
In Commercial Distribution
MEDTRONIC, INC.
STENT GRAFT ETLW1613C124E ENDUR II LIMB
Device Characteristics
| MR Conditional | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 46777 | Aortoiliac endovascular stent-graft |
A 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) [includes aortoiliac aneurysm]; it does not contain anticoagulants or pharmaceuticals. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is made of a metallic mesh structure with a polymer tube (endovascular graft) and is typically available as a: 1) single tube for insertion into the aorta and/or one iliac artery; or 2) two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries.
|
Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| MIH | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| P100021 | 024 |
| P100021 | 032 |
| P100021 | 039 |
| P100021 | 041 |
| P100021 | 058 |
| P100021 | 063 |
| P100021 | 077 |
| P100021 | 083 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Special Storage Condition, Specify: Store the system at room temperature in a dark, dry place. |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: Stent Graft Covered Length 124 MM |
| Device Size Text, specify: Stent Graft Proximal Diameter 16 MM |
| Device Size Text, specify: Stent Graft Distal Diameter 13 MM |
Device Record Status
b55b5ad3-00c8-46f0-b596-467d7161049b
September 24, 2025
10
November 06, 2014
September 24, 2025
10
November 06, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com