Optune®
FDA premarket approval P100034/S040 · decided 2025-06-06
Approval details
- PMA number
- P100034
- Supplement
- S040
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Optune®
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2025-05-08
- Decision date
- 2025-06-06
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- the implementation of a second-source supplier of Li-Ion battery cells
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