Data / Medical devices / United States / Novocure Inc
Novocure Inc: FDA-registered device maker in Portsmouth, NH, United States, 3 PMA approvals
Novocure Inc is registered with the FDA (registration 3009306483) in Portsmouth, NH, United States. It lists 4 device types. The FDA files 3 PMA approvals under its listings, the newest dated February 11, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009306483
- Address
- 195 Commerce Way, Portsmouth, NH, United States, 03801
- Owner or operator
- NOVOCURE INC (10040460)
- Roles
- Manufacturer
- First device listed
- April 17, 2012
- Registered through
- 2026
- Brand names listed
- Optune Lua, Optune Lua Treatment Kit, Optune Pax, Optune Treatment Kit, Transducer Array
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrical Tumor Treatment Fields | QGZ | 3 | Manufacturer | accessdata.fda.gov |
| Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer | SDA | 3 | Manufacturer | accessdata.fda.gov |
| Low Electric Field Generator For Pancreatic Cancer Treatment | SHC | 3 | Manufacturer | accessdata.fda.gov |
| Stimulator, Low Electric Field, Tumor Treatment | NZK | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 11, 2026 | P250034 | Optune Pax | SHC | 1 | July 1, 2026 | accessdata.fda.gov |
| October 15, 2024 | P230042 | Optune Lua | SDA | 6 | July 1, 2026 | accessdata.fda.gov |
| April 8, 2011 | P100034 | NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT | NZK | 45 | September 18, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Low Electric Field Generator For Pancreatic Cancer Treatment
- All makers of Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer
- All makers of Stimulator, Low Electric Field, Tumor Treatment
- All makers of Electrical Tumor Treatment Fields
Updated July 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.