PMA P250034
- Device
- Optune Pax
- Applicant
- Novocure, GmbH
- Product code
- SHC
- Decision date
- 2026-02-11
- Generic name
- Low Electric Field Generator for Pancreatic Cancer Treatment
- Approval order statement
- Optune Pax is intended for treatment of adult patients with locally advanced pancreatic cancer, concomitant with gemcitabine and nab-paclitaxel.
Current openFDA PMA Record#
- Device
- Optune Pax
- Applicant
- Novocure, GmbH
- PMA number
- P250034
- Product code
- SHC
- Generic name
- Low Electric Field Generator for Pancreatic Cancer Treatment
- Decision date
- 2026-02-11
- Decision code
- APPR
- Date received
- 2025-08-15
- Approval order statement
- Optune Pax is intended for treatment of adult patients with locally advanced pancreatic cancer, concomitant with gemcitabine and nab-paclitaxel.