Optune
FDA premarket approval P100034/S018 · decided 2018-11-30
Approval details
- PMA number
- P100034
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Optune
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2018-06-05
- Decision date
- 2018-11-30
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- Approval to update the Optune device labeling with the clinical outcome data from the pivotal study conducted to treat newly diagnosed glioblastoma (Long-Term EF-14).
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