NOVOCURE'S OPTUNE SYSTEM
FDA premarket approval P100034/S014 · decided 2016-02-09
Approval details
- PMA number
- P100034
- Supplement
- S014
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- NOVOCURE'S OPTUNE SYSTEM
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2015-08-21
- Decision date
- 2016-02-09
- Days to decision
- 172 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- Approval of the following changes to the post-approval study for the device: modification to enrollment criteria.
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