Optune System
FDA premarket approval P100034/S019 · decided 2018-12-19
Approval details
- PMA number
- P100034
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Optune System
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2018-09-20
- Decision date
- 2018-12-19
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- Approval for changes to Optune System carrying case and INE Transducer Array package sizes; Optune System software modifications increasing the secondary alarm threshold for INE Transducer Array partial attachment, correcting data transfer processing following switch from battery to mains power, and eliminating a redundant INE Transducer Array overheating alarm; and NovoTerminal software modifications improving Optune System data transfer processing.
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