Novocure Ltd.'s Optune
FDA premarket approval P100034/S017 · decided 2017-03-15
Approval details
- PMA number
- P100034
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Novocure Ltd.'s Optune
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2017-02-13
- Decision date
- 2017-03-15
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- Addition of two second source component suppliers related to the INE transducer array subassembly as well as automation of a related soldering procedure.
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