CoreValve™ Evolut™

GUDID 00643169430280

VALVE MCS-P3-31-AOA TAV 31 US COMM SA

MEDTRONIC COREVALVE LLC

Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework
Primary Device ID00643169430280
NIH Device Record Keyd8972646-54ab-4604-976c-cb82ae44222e
Commercial Distribution Discontinuation2015-12-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCoreValve™ Evolut™
Version Model NumberMCS-P3-31-AOA
Company DUNS079527231
Company NameMEDTRONIC COREVALVE LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0
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Device Size Text, specify0
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Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169430280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPTAortic valve, prosthesis, percutaneously delivered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-23

On-Brand Devices [CoreValve™ Evolut™]

00643169448551VALVE MCS-P3-31-AOA-US TAV 31 US COMM MX
00643169448544VALVE MCS-P3-29-AOA-US TAV 29 US COMM MX
00643169448537VALVE MCS-P3-26-AOA-US TAV 26 US COMM MX
00643169448520VALVE MCS-P4-23-AOA-US TAV 23 US COMM MX
00643169448513VALVE MCS-P3-31-AOA-US TAV 31 US COMM SA
00643169448506VALVE MCS-P3-29-AOA-US TAV 29 US COMM SA
00643169448490VALVE MCS-P3-26-AOA-US TAV 26 US COMM SA
00643169448483VALVE MCS-P4-23-AOA-US TAV 23 US COMM SA
00643169430310VALVE MCS-P4-23-AOA TAV 23 US COMM MX
00643169430303VALVE MCS-P4-23-AOA TAV 23 US COMM SA
00643169430297VALVE MCS-P3-31-AOA TAV 31 US COMM MX
00643169430280VALVE MCS-P3-31-AOA TAV 31 US COMM SA
00643169430273VALVE MCS-P3-29-AOA TAV 29 US COMM MX
00643169430266VALVE MCS-P3-29-AOA TAV 29 US COMM SA
00643169430259VALVE MCS-P3-26-AOA TAV 26 US COMM MX
00643169430242VALVE MCS-P3-26-AOA TAV 26 US COMM SA

Trademark Results [CoreValve]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COREVALVE
COREVALVE
77418215 3688088 Live/Registered
MEDTRONIC CV LUXEMBOURG S.A.R.L.
2008-03-10
COREVALVE
COREVALVE
77243631 3405124 Live/Registered
MEDTRONIC CV LUXEMBOURG S.A.R.L.
2007-07-31

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