DEVICE: Endurant® II (00763000305840)
Device Identifier (DI) Information
Endurant® II
ETTF3232C70E
In Commercial Distribution
MEDTRONIC, INC.
ETTF3232C70E
In Commercial Distribution
MEDTRONIC, INC.
STENT GRAFT ETTF3232C70E ENDUR II AOEXT
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); it does not contain anticoagulants or pharmaceuticals that prevent narrowing of the vessels. 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 in two designs: 1) a single tube for insertion into one iliac artery; or 2) a 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 | 011 |
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 Length (Covered) 70 MM |
Device Size Text, specify: Stent Graft Proximal Diameter 32 MM |
Device Size Text, specify: Stent Graft Distal Diameter 32 MM |
Device Record Status
654a39ef-2b07-4ea9-92c2-254b84e353d2
January 10, 2023
6
November 21, 2020
January 10, 2023
6
November 21, 2020
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