Optune System
FDA premarket approval P100034/S022 · decided 2019-02-28
Approval details
- PMA number
- P100034
- Supplement
- S022
- 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
- 2018-11-30
- Decision date
- 2019-02-28
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- Approval for a color change to the INE Transducer Array medical tape from white to tan, and a change to the release liner of the INE Transducer Array from a paper-based material to polyester.
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