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CoreValve™ Evolut™

FDA UDI

Class III (US FDA UDI)

by Medtronic Core Valve, LLC

Identity

Trade Name
CoreValve™ Evolut™ FDA UDI
Generic Name
Aortic transcatheter heart valve bioprosthesis, stent-like framework FDA UDI
Device Name
VALVE MCS-P3-31-AOA-US TAV 31 US COMM SA FDA UDI
Model / Reference
MCS-P3-31-AOA-US FDA UDI
Description
VALVE MCS-P3-31-AOA-US TAV 31 US COMM SA FDA UDI

Identifiers

Primary DI / UDI-DI
00643169448513 FDA UDI
PMA Number
P130021 FDA UDI
FDA Product Code
NPT FDA UDI
GMDN Term
Aortic transcatheter heart valve bioprosthesis, stent-like framework FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

CoreValve™ Evolut™ by Medtronic Core Valve, LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P130021 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Core Valve, LLC

Sources (1)

  • FDA UDI 4edcbac0-5390-4afc-9239-5909fa0025d4 38 fields · synced May 30, 2026