NOVOTTF-100A SYSTEM
FDA premarket approval P100034/S012 · decided 2015-03-23
Approval details
- PMA number
- P100034
- Supplement
- S012
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NOVOTTF-100A SYSTEM
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2014-09-24
- Decision date
- 2015-03-23
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- APPROVAL FOR AN ADDITIONAL SUPPLIER FOR THE CONVERTER.
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