FDA Device Establishments · JSON-LD · Markdown
FEI 3007904765 · Manufacture Medical Device · Status: Active
| FEI Number | 3007904765 |
|---|---|
| Owner / Operator | Abiomed Europe GmbH (#10030761) |
| Address | Neuenhofer Weg 3, Aachen North Rhine-Westphalia, 52074, DE |
| Mandatory US Agent | Abiomed, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | PYX |
| Regulation § (21 CFR) | 870.4360 |
| Proprietary names | Impella RP; Impella RP Flex with SmartAssist; Impella RP with SmartAssist |
Source: openFDA. Public-domain (CC0).