FDA Device Establishments · JSON-LD · Markdown
FEI 3015179394 · Manufacture Medical Device · Status: Active
| FEI Number | 3015179394 |
|---|---|
| Owner / Operator | Edwards Lifesciences LLC (#9040666) |
| Address | 10 Earhart Ave, Shannon Industrial Estates, Shannon Clare, V14 P638, IE |
| Mandatory US Agent | EDWARDS LIFESCIENCES LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | QWA |
| Regulation § (21 CFR) | 870.3955 |
| Proprietary names | SAPIEN M3 TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM; Edwards Reusable Accessories - Reusable Cradle; Edwards EVOQUE Accessories; PASCAL System - Table; Edwards Reusable Rail Extension; Edwards Reusable Accessories - Reusable Platform; Edwards Stabilizer Rail System; Edwards Rail Tray; PASCAL System - Stabilizer Rail System; Edwards Reusable Accessories - Reusable Plate |
Source: openFDA. Public-domain (CC0).