PMA P250034
- Device
- Optune Pax®
- Applicant
- Novocure, GmbH
- Product code
- SHC
- Decision date
- 2026-07-01
- Generic name
- Low Electric Field Generator for Pancreatic Cancer Treatment
- Approval order statement
- approval for extending the shelf life of the sterilized ITE transducer array from nine months to twelve months.
Current openFDA PMA Record#
- Device
- Optune Pax®
- Applicant
- Novocure, GmbH
- PMA number
- P250034
- Supplement
- S001
- Product code
- SHC
- Generic name
- Low Electric Field Generator for Pancreatic Cancer Treatment
- Decision date
- 2026-07-01
- Decision code
- APPR
- Date received
- 2026-04-24
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for extending the shelf life of the sterilized ITE transducer array from nine months to twelve months.