NOVOTTF-100A SYSTEM
FDA premarket approval P100034/S003 · decided 2013-04-17
Approval details
- PMA number
- P100034
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NOVOTTF-100A SYSTEM
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2013-01-29
- Decision date
- 2013-04-17
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- APPROVAL FOR SOFTWARE MODIFICATION TO ADD AN ALARM TO THE IDLE LOOP (THE NON-TREATMENT LOOP) TO INDICATE THAT THE DEVICE IS STILL POWERED ON EVEN WHEN TREATMENT IS NOT ACTIVE.
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