Evolut™ FX

GUDID 00763000370688

VLV EVOLUTFX-23 COMM US

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 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 ID00763000370688
NIH Device Record Key3c99ee2d-a595-4f7b-8a77-9c68aa6c2631
Commercial Distribution StatusIn Commercial Distribution
Brand NameEvolut™ FX
Version Model NumberEVOLUTFX-23
Company DUNS079527231
Company NameMEDTRONIC COREVALVE LLC
Device Count1
DM Exempttrue
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
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
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000370688 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-17
Device Publish Date2021-12-09

On-Brand Devices [Evolut™ FX]

00763000365707Loading Sys L-EVOLUTFX-34
00763000365691Loading Sys L-EVOLUTFX-2329
00763000365684Deliv Sys D-EVOLUTFX-34
00763000365677Deliv Sys D-EVOLUTFX-2329
00763000370718VLV EVOLUTFX-34 COMM US ROW
00763000370701VLV EVOLUTFX-29 COMM US
00763000370695VLV EVOLUTFX-26 COMM US
00763000370688VLV EVOLUTFX-23 COMM US

Trademark Results [Evolut]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EVOLUT
EVOLUT
97694948 not registered Live/Pending
Zhuhai Dibang Printing Consumables Co.,Ltd.
2022-11-28
EVOLUT
EVOLUT
85622806 4667967 Live/Registered
Medtronic CV Luxembourg S.A.R.L.
2012-05-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.