Identity
- Trade Name
- EnVeo™ PRO FDA UDI
- Generic Name
- Aortic transcatheter heart valve bioprosthesis, stent-like framework FDA UDI
- Device Name
- 18FR DELIV SYS ENVPRO-14-US FDA UDI
- Model / Reference
- ENVPRO-14-US FDA UDI
- Description
- 18FR DELIV SYS ENVPRO-14-US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169987203 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 6.0 Millimeter FDA UDILength — 107.0 Centimeter FDA UDI
Category: Aortic transcatheter heart valve bioprosthesis, stent-like framework
EnVeo™ PRO by Medtronic, Inc. — 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.
- Evolut™ FX — Medtronic Core Valve, LLC · Class III
- CoreValve™ Evolut™ PRO — Medtronic Core Valve, LLC · Class III
- EnVeo™ R — Medtronic Core Valve, LLC · Class III
- SAPIEN 3 Ultra RESILIA — Edwards Lifesciences LLC · Class III
- 23MM X 3CM X 105CM NOVAFLEX+ DELIVERY SYSTEM — Edwards Lifesciences LLC · Class III
- EDWARDS CERTITUDE INTRODUCER SHEATH SET — Edwards Lifesciences LLC · Class III
- CoreValve™ Evolut™ R — Medtronic Core Valve, LLC · Class III
- Evolut™ PRO+ — Medtronic Core Valve, LLC · Class III
Cleared under the same submission
P130021 also covers:
- 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
- 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, Inc.
Sources (1)
- FDA UDI 9fbb9ea6-489d-4529-8bdf-8338b353c8ed 37 fields · synced May 29, 2026