CoreValve™ Evolut™
GUDID 00643169448483
VALVE MCS-P4-23-AOA-US TAV 23 US COMM SA
MEDTRONIC COREVALVE LLC
Aortic transcatheter heart valve bioprosthesis, stent-like framework| Primary Device ID | 00643169448483 |
| NIH Device Record Key | 8193ba1f-08fd-4755-a229-ab1001113d1d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoreValve™ Evolut™ |
| Version Model Number | MCS-P4-23-AOA-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 |
| 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
| 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 |
| 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 |
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169448483 [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 | 2014-09-23 |
On-Brand Devices [CoreValve™ Evolut™]
| 00643169448551 | VALVE MCS-P3-31-AOA-US TAV 31 US COMM MX |
| 00643169448544 | VALVE MCS-P3-29-AOA-US TAV 29 US COMM MX |
| 00643169448537 | VALVE MCS-P3-26-AOA-US TAV 26 US COMM MX |
| 00643169448520 | VALVE MCS-P4-23-AOA-US TAV 23 US COMM MX |
| 00643169448513 | VALVE MCS-P3-31-AOA-US TAV 31 US COMM SA |
| 00643169448506 | VALVE MCS-P3-29-AOA-US TAV 29 US COMM SA |
| 00643169448490 | VALVE MCS-P3-26-AOA-US TAV 26 US COMM SA |
| 00643169448483 | VALVE MCS-P4-23-AOA-US TAV 23 US COMM SA |
| 00643169430310 | VALVE MCS-P4-23-AOA TAV 23 US COMM MX |
| 00643169430303 | VALVE MCS-P4-23-AOA TAV 23 US COMM SA |
| 00643169430297 | VALVE MCS-P3-31-AOA TAV 31 US COMM MX |
| 00643169430280 | VALVE MCS-P3-31-AOA TAV 31 US COMM SA |
| 00643169430273 | VALVE MCS-P3-29-AOA TAV 29 US COMM MX |
| 00643169430266 | VALVE MCS-P3-29-AOA TAV 29 US COMM SA |
| 00643169430259 | VALVE MCS-P3-26-AOA TAV 26 US COMM MX |
| 00643169430242 | VALVE MCS-P3-26-AOA TAV 26 US COMM SA |
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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