Optune® device
FDA premarket approval P100034/S029 · decided 2022-05-10
Approval details
- PMA number
- P100034
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Optune® device
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2022-02-14
- Decision date
- 2022-05-10
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- Approval for changes to the specifications of the ceramic discs used in the INE Transducer Arrays to make them lead-free, and the addition of a new supplier for these lead-free ceramic discs, Vishay Electronics GmbH, located at Dr.-Felix-Zandman-Platz 1, Selb 95100, Germany.
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