Evolut™ FX
GUDID 00763000370718
VLV EVOLUTFX-34 COMM US ROW
MEDTRONIC COREVALVE LLC
Aortic transcatheter heart valve bioprosthesis, stent-like framework| Primary Device ID | 00763000370718 |
| NIH Device Record Key | 53e10351-06aa-475e-8591-fb79db2980a4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Evolut™ FX |
| Version Model Number | EVOLUTFX-34 |
| Company DUNS | 079527231 |
| Company Name | MEDTRONIC COREVALVE LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| 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
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000370718 [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 | 2021-12-17 |
| Device Publish Date | 2021-12-09 |
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 |
| 00763000942731 | LOADING SYS L-EVOLUTFX-34 |
| 00763000942724 | LOADING SYS L-EVOLUTFX-2329 |
| 00763000942717 | DELIV SYS D-EVOLUTFX-34 |
| 00763000942700 | DELIV SYS D-EVOLUTFX-2329 |
Trademark Results [Evolut]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EVOLUT 97694948 not registered Live/Pending |
Zhuhai Dibang Printing Consumables Co.,Ltd. 2022-11-28 |
 EVOLUT 85622806 4667967 Live/Registered |
Medtronic CV Luxembourg S.A.R.L. 2012-05-11 |
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