DEVICE: CoreValve™ Evolut™ (00643169430303)

Device Identifier (DI) Information

CoreValve™ Evolut™
MCS-P4-23-AOA
Not in Commercial Distribution

MEDTRONIC COREVALVE LLC
00643169430303
GS1
December 21, 2015
1
079527231 *Terms of Use
VALVE MCS-P4-23-AOA TAV 23 US COMM SA
CLOSE

Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Aortic transcatheter heart valve bioprosthesis, stent-like framework A sterile implantable xenograft (e.g., bovine) intended to be used to repair/replace a stenosed 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) 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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
NPT Aortic valve, prosthesis, percutaneously delivered
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: more than 0 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Valve Size 23 MM
CLOSE

Device Record Status

68d77e13-563c-4e26-b36a-4e8c0916e35d
March 29, 2018
2
September 23, 2014
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

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