HDE supplement
H180002 S004: Optune Lua
FDA HDE supplement · 30-day notice · Novocure, GmbH
Key facts
| Original HDE | H180002 |
|---|---|
| Supplement number | S004 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | Optune Lua |
| Generic name | Electrical tumor treatment fields |
| Applicant | Novocure, GmbH |
| Product code | QGZ |
| Received date | May 21, 2025 |
| Decision date | Jun 4, 2025 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: