CoreValve™ Evolut™ R
GUDID 00763000017651
VLV EVOLUTR-23-US GREY COMM US
MEDTRONIC COREVALVE LLC
Aortic transcatheter heart valve bioprosthesis, stent-like framework| Primary Device ID | 00763000017651 |
| NIH Device Record Key | b3e4f0e7-aaaa-4211-aab1-1f2c71dfb5f9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoreValve™ Evolut™ R |
| Version Model Number | EVOLUTR-23-US |
| Company DUNS | 079527231 |
| Company Name | MEDTRONIC COREVALVE LLC |
| Device Count | 1 |
| DM Exempt | false |
| 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 |
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Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000017651 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-02-01 |
On-Brand Devices [CoreValve™ Evolut™ R]
| 00643169792340 | VLV EVOLUTR-34-US TAV 34 US COMM MX |
| 00643169638006 | VLV EVOLUTR-29-US TAV 29 US COMM MX |
| 00643169637993 | VLV EVOLUTR-26-US TAV 26 US COMM MX |
| 00643169637986 | VLV EVOLUTR-23-US TAV 23 US COMM MX |
| 00763000017682 | VLV EVOLUTR-34-US BLUE COMM US |
| 00763000017675 | VLV EVOLUTR-29-US GREY COMM US |
| 00763000017668 | VLV EVOLUTR-26-US GREY COMM US |
| 00763000017651 | VLV EVOLUTR-23-US GREY COMM US |
Trademark Results [CoreValve]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COREVALVE 77418215 3688088 Live/Registered |
MEDTRONIC CV LUXEMBOURG S.A.R.L. 2008-03-10 |
 COREVALVE 77243631 3405124 Live/Registered |
MEDTRONIC CV LUXEMBOURG S.A.R.L. 2007-07-31 |
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