DEVICE: CoreValve™ Evolut™ R (00643169637993)
Device Identifier (DI) Information
CoreValve™ Evolut™ R
EVOLUTR-26-US
In Commercial Distribution
MEDTRONIC COREVALVE LLC
EVOLUTR-26-US
In Commercial Distribution
MEDTRONIC COREVALVE LLC
VLV EVOLUTR-26-US TAV 26 US COMM MX
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? |
---|---|---|---|---|
60245 | Aortic transcatheter heart valve bioprosthesis, stent-like framework |
An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral, subclavian, aortic) or transapical access while the heart is beating. It is comprised of the xenograft, processed to render the tissue non-viable, attached to an expandable metal framework, which is implanted with an included catheter, and when in situ, may be expanded with a balloon or self-expand. Typically devices associated with implantation (e.g., catheter, introducer) are included.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NPT | Aortic valve, prosthesis, percutaneously delivered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P130021 | 014 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep Dry |
Storage Environment Temperature: more than 0 Degrees Celsius |
Special Storage Condition, Specify: Keep Away from Sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Valve Size 26 MM |
Device Record Status
1f8889e2-fe0b-42f3-aab2-bec03f11355c
July 04, 2022
5
June 29, 2015
July 04, 2022
5
June 29, 2015
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