DEVICE: Vela Proximal Endograft System (00818009013576)
Device Identifier (DI) Information
Vela Proximal Endograft System
A25-25/C75-O20 V
In Commercial Distribution
ENDOLOGIX, INC.
A25-25/C75-O20 V
In Commercial Distribution
ENDOLOGIX, INC.
No description.
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 | Abdominal aorta 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 typically made of a metallic outer mesh structure with an inner 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 [?] |
---|---|
P040002 | 041 |
P040002 | 042 |
P040002 | 043 |
P040002 | 044 |
P040002 | 045 |
P040002 | 046 |
P040002 | 047 |
P040002 | 048 |
P040002 | 050 |
P040002 | 051 |
P040002 | 052 |
P040002 | 053 |
P040002 | 054 |
P040002 | 056 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 25 mm, Proximal Diameter |
Device Size Text, specify: 25 mm, Distal Diameter |
Device Size Text, specify: 75 mm, Covered Extension Length |
Device Size Text, specify: 20 mm, Uncovered Extension Length |
Device Record Status
4d0e2e48-7db1-436e-a8e4-5beb9ac99ff6
December 11, 2024
9
September 24, 2014
December 11, 2024
9
September 24, 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
[?]
(949) 595-7200
CustomerService@endologix.com
CustomerService@endologix.com