DEVICE: Evolut™ FX (00763000365677)
Device Identifier (DI) Information
Evolut™ FX
D-EVOLUTFX-2329
In Commercial Distribution
MEDTRONIC COREVALVE LLC
D-EVOLUTFX-2329
In Commercial Distribution
MEDTRONIC COREVALVE LLC
Deliv Sys D-EVOLUTFX-2329
Device Characteristics
Labeling does not contain MRI Safety Information | |
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.
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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 | 094 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store the catheter and loading system in a cool, dry environment. |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 6.0 Millimeter |
Length: 108.0 Centimeter |
Device Record Status
c7122d24-94b0-4908-abad-7668ff501f2b
July 04, 2022
2
November 29, 2021
July 04, 2022
2
November 29, 2021
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 |
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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