PMA supplement
P100034 S032: Optune
FDA PMA supplement · Normal 180 Day Track No User Fee · Novocure, GmbH
Key facts
| Original PMA | P100034 |
|---|---|
| Supplement number | S032 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Optune |
| Generic name | Stimulator, low electric field, tumor treatment |
| Applicant | Novocure, GmbH |
| Product code | NZK |
| Received date | Jul 25, 2023 |
| Decision date | Feb 2, 2024 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: