Optune System
FDA premarket approval P100034/S023 · decided 2020-03-15
Approval details
- PMA number
- P100034
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Optune System
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2020-02-14
- Decision date
- 2020-03-15
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- Move certain assembly activities performed for the Optune System from one building to another at the approved contract manufacturers site.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.