NOVOCURE NOVOTTF-100A SYSTEM
FDA premarket approval P100034/S001 · decided 2012-01-03
Approval details
- PMA number
- P100034
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- NOVOCURE NOVOTTF-100A SYSTEM
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2011-05-04
- Decision date
- 2012-01-03
- Days to decision
- 244 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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