CoreValve™ Evolut™ PRO
GUDID 00643169954434
VLV EVOLUTPRO-23-US PRO BLNK US
MEDTRONIC COREVALVE LLC
Aortic transcatheter heart valve bioprosthesis, stent-like framework| Primary Device ID | 00643169954434 |
| NIH Device Record Key | 08147bb8-0e1a-406b-95da-76dc0c05a21b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoreValve™ Evolut™ PRO |
| Version Model Number | EVOLUTPRO-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 |
| 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 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| 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 | 00643169954434 [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 | 2017-03-31 |
On-Brand Devices [CoreValve™ Evolut™ PRO]
| 00643169954458 | VLV EVOLUTPRO-29-US PRO BLNK US |
| 00643169954441 | VLV EVOLUTPRO-26-US PRO BLNK US |
| 00643169954434 | VLV EVOLUTPRO-23-US PRO BLNK US |
| 00763000017835 | VLV EVOLUTPRO-29-US BLUE COMM US |
| 00763000017828 | VLV EVOLUTPRO-26-US BLUE COMM US |
| 00763000017811 | VLV EVOLUTPRO-23-US BLUE 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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