Optune System
FDA premarket approval P100034/S025 · decided 2021-03-09
Approval details
- PMA number
- P100034
- Supplement
- S025
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Optune System
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2021-01-08
- Decision date
- 2021-03-09
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- Approval for a manufacturing site, Flex-Romania, located at Calea Torontalului, DN 6, Km 5,7, Timisoara, Romania 300668 to manufacture the INE Transducer Arrays in the Optune System.
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