DEVICE: Evolut™ FX (00763000365677)

Device Identifier (DI) Information

Evolut™ FX
D-EVOLUTFX-2329
In Commercial Distribution

MEDTRONIC COREVALVE LLC
00763000365677
GS1

1
079527231 *Terms of Use
Deliv Sys D-EVOLUTFX-2329
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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.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
NPT Aortic valve, prosthesis, percutaneously delivered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P130021 094
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store the catheter and loading system in a cool, dry environment.
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 6.0 Millimeter
Length: 108.0 Centimeter
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Device Record Status

c7122d24-94b0-4908-abad-7668ff501f2b
July 04, 2022
2
November 29, 2021
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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