FDA device listing
Impella RP,Impella RP Flex with SmartAssist,Impella RP with SmartAssist
FDA device listing 1718042238 · Abiomed Europe GmbH
Key facts
| Proprietary names | Impella RP,Impella RP Flex with SmartAssist,Impella RP with SmartAssist |
|---|---|
| Owner/operator | Abiomed Europe GmbH |
| Owner/operator number | 10030761 |
| Premarket submissions | P170011 |
| Product codes | PYX |
| Device names | PYX - Temporary Non-Roller Type Right Heart Support Blood Pump |
| Device class | Class III |
| Classification regulations (21 CFR) | 870.4360 |
| Review panels | Cardiovascular |
| Registered establishments | ABIOMED EUROPE GMBH |
| Establishment registrations | 3007904765 |
| FEI numbers | 3007904765 |
| Establishment operations | Manufacturer |
| 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