FDA Device Establishments · JSON-LD · Markdown
FEI 3007063218 · Manufacture Medical Device · Status: Active
| FEI Number | 3007063218 |
|---|---|
| Owner / Operator | Edwards Lifesciences LLC (#9040666) |
| Address | 35 Changi North Crescent, Changi South East, 499641, SG |
| Mandatory US Agent | EDWARDS LIFESCIENCES LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | NPV |
| Proprietary names | Edwards Commander Delivery System; Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards Crimper; Edwards SAPIEN 3 Pulmonic Delivery System; Edwards SAPIEN 3 Transcather Pulmonary Valve System with Alterra Adaptive Prestent; Edwards SAPIEN 3 Transcatheter Pulmonic Valve Delivery System |
Source: openFDA. Public-domain (CC0).