NOVOTFF-100A SYSTEM
FDA premarket approval P100034/S007 · decided 2014-11-12
Approval details
- PMA number
- P100034
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NOVOTFF-100A SYSTEM
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2014-05-12
- Decision date
- 2014-11-12
- Days to decision
- 184 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- APPROVAL FOR CHANGES TO THE NOVOTTF-100A INSULATED ELECTRODE (INE) TRANSDUCER ARRAY MANUFACTURING PROCESS TO IMPROVE ITS EFFICIENCY BY AUTOMATING CERTAIN MANUAL PROCESSING STEPS.
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