Evolut™ FX

GUDID 00763000365691

Loading Sys L-EVOLUTFX-2329

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 ID: 00763000365691
• NIH Device Record Key: 24dad6a3-3926-443a-a960-a1ce8e601bef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evolut™ FX
• Version Model Number: L-EVOLUTFX-2329
• Company DUNS: 079527231
• Company Name: MEDTRONIC COREVALVE LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and loading system in a cool, dry environment.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000365691 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130021

FDA Product Code

• NPT: Aortic valve, prosthesis, percutaneously delivered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-07
• Device Publish Date: 2021-11-29

On-Brand Devices [Evolut™ FX]

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