Optune System
FDA premarket approval P100034/S028 · decided 2021-05-24
Approval details
- PMA number
- P100034
- Supplement
- S028
- 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
- 2021-03-22
- Decision date
- 2021-05-24
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- Approval for a manufacturing site, Synergy Health Däniken AG (Steris), located at Hogenweidstrasse 6, CH-4658, Daniken, Switzerland. This site is a sterilization facility used to sterilize the INE Transducer Arrays in the Optune System.
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