CoreValve™ Evolut™ PRO

GUDID 00763000017811

VLV EVOLUTPRO-23-US BLUE COMM US

MEDTRONIC COREVALVE LLC

Aortic transcatheter heart valve bioprosthesis, stent-like framework
Primary Device ID00763000017811
NIH Device Record Key4289e00e-aa0c-40eb-9d6e-b116f8346220
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoreValve™ Evolut™ PRO
Version Model NumberEVOLUTPRO-23-US
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
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

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000017811 [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 Date2018-02-01

On-Brand Devices [CoreValve™ Evolut™ PRO]

00643169954458VLV EVOLUTPRO-29-US PRO BLNK US
00643169954441VLV EVOLUTPRO-26-US PRO BLNK US
00643169954434VLV EVOLUTPRO-23-US PRO BLNK US
00763000017835VLV EVOLUTPRO-29-US BLUE COMM US
00763000017828VLV EVOLUTPRO-26-US BLUE COMM US
00763000017811VLV EVOLUTPRO-23-US BLUE COMM US

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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