Identity
- Trade Name
- Evolut™ PRO+ FDA UDI
- Generic Name
- Aortic transcatheter heart valve bioprosthesis, stent-like framework FDA UDI
- Device Name
- VLV EVPROPLUS-29 COMM US FDA UDI
- Model / Reference
- EVPROPLUS-29US FDA UDI
- Description
- VLV EVPROPLUS-29 COMM US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000211127 FDA UDI
- PMA Number
- P130021 FDA UDI
- FDA Product Code
- NPT FDA UDI
- GMDN Term
- Aortic transcatheter heart valve bioprosthesis, stent-like framework FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Aortic transcatheter heart valve bioprosthesis, stent-like framework
Evolut™ PRO+ by Medtronic Core Valve, LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aortic transcatheter heart valve bioprosthesis, stent-like framework.
- EnVeo™ PRO — MEDTRONIC, INC. · Class III
- SAPIEN 3 Ultra RESILIA — Edwards Lifesciences LLC · Class III
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- SAPIEN 3 Ultra Delivery System — Edwards Lifesciences LLC · Class III
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) — Edwards Lifesciences LLC · Class III
- EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) — Edwards Lifesciences LLC · Class III
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE (THV) — Edwards Lifesciences LLC · Class III
Cleared under the same submission
P130021 also covers:
- EnVeo™ PRO — MEDTRONIC, INC.
- EnVeo™ PRO — MEDTRONIC, INC.
- EnVeo™ PRO — MEDTRONIC, INC.
- EnVeo™ PRO — MEDTRONIC, INC.
- CoreValve™ Evolut™ PRO — Medtronic Core Valve, LLC
- CoreValve™ Evolut™ PRO — Medtronic Core Valve, LLC
- CoreValve™ Evolut™ PRO — Medtronic Core Valve, LLC
- CoreValve™ Evolut™ R — Medtronic Core Valve, LLC
- CoreValve™ Evolut™ R — Medtronic Core Valve, LLC
- CoreValve™ Evolut™ R — Medtronic Core Valve, LLC
- CoreValve™ Evolut™ R — Medtronic Core Valve, LLC
- CoreValve™ Evolut™ R — Medtronic Core Valve, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Core Valve, LLC
Sources (1)
- FDA UDI 41855744-0906-4b64-869d-a8aa4e5ebd95 37 fields · synced May 30, 2026