FDA device listing
CoreValve Evolut PRO System,CoreValve Evolut PRO+ System,CoreValve Evolut R System,Evolut FX+ System,Medtronic CoreValve…
FDA device listing 1343864551 · Medtronic, Inc.
Key facts
| Proprietary names | CoreValve Evolut PRO System,CoreValve Evolut PRO+ System,CoreValve Evolut R System,Evolut FX+ System,Medtronic CoreValve System,Medtronic Evolut FX System |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Premarket submissions | P130021 |
| Product codes | NPT |
| Device names | NPT - Aortic Valve, Prosthesis, Percutaneously Delivered |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.NPT |
| Review panels | Cardiovascular |
| Registered establishments | Medtronic Distribution Center, Medtronic Heart Valves Division, MEDTRONIC IRELAND, Medtronic Mexico S. de R.L. de CV |
| Establishment registrations | 2025587, 9612164, 9617601, 3009380063 |
| FEI numbers | 2025587, 3002534070, 3002806434, 3009380063 |
| Establishment operations | Manufacturer, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database