Identity
- Trade Name
- Optune Pax FDA PMA
- Generic Name
- Low Electric Field Generator for Pancreatic Cancer Treatment FDA PMA
Identifiers
- PMA Number
- P250034 FDA PMA
- FDA Product Code
- SHC FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- General, Plastic Surgery FDA PMA
- FDA Decision
- APPR Approved FDA PMA
Optune Pax is a low electric field generator designed for the treatment of adult patients diagnosed with locally advanced pancreatic cancer. It is intended to be used in conjunction with gemcitabine and nab-paclitaxel chemotherapy regimens.
This device is manufactured by Novocure GmbH and is authorized under FDA PMA P250034. It is classified as a class 3 medical device and is intended for clinical application as specified in the regulatory documentation.
Frequently asked questions
What is the primary function of the Optune Pax?
The Optune Pax is a low electric field generator specifically designed to treat adult patients who have been diagnosed with locally advanced pancreatic cancer.
How is the Optune Pax used in a clinical setting?
The device is intended to be used concomitantly with gemcitabine and nab-paclitaxel, which are standard chemotherapy treatments for pancreatic cancer.
Is the Optune Pax authorized for medical use?
Yes, the device has received FDA PMA authorization under reference number P250034, confirming it has met the necessary regulatory requirements for its intended use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Active |
| FDA PMA | United States | FDA_PMA | P250034 | Class III | Active |
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Manufacturer
- Manufacturer
- Novocure GmbH
- FDA Applicant
- Novocure, GmbH
Sources (2)
- FDA PMA P250034 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026