PMA
P250034: Optune Pax
FDA PMA · Low Electric Field Generator for Pancreatic Cancer Treatment · Novocure, GmbH
Key facts
| PMA number | P250034 |
|---|---|
| Trade name | Optune Pax |
| Generic name | Low Electric Field Generator for Pancreatic Cancer Treatment |
| Applicant | Novocure, GmbH |
| Owner/operator | NOVOCURE GmbH |
| Product code | SHC |
| Approval date | Feb 11, 2026 |
| Docket number | FDA-1893 |
| Establishment registration | 3010457505 |
| FEI number | 3010457505 |
At a glance
- 1–9 Supplements
- Jul 1, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: