OPTUNE
FDA premarket approval P100034/S015 · decided 2016-07-13
Approval details
- PMA number
- P100034
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OPTUNE
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2015-12-22
- Decision date
- 2016-07-13
- Days to decision
- 204 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- Approval for a smaller, lighter weight version of the original Optune System, referred to as the Optune System (NovoTTF-200A System).
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