PMA P100034S023
- Device
- Optune System
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S023
- Product code
- NZK
- Decision date
- 2020-03-15
- Generic name
- Stimulator, low electric field, tumor treatment
- Approval order statement
- Move certain assembly activities performed for the Optune System from one building to another at the approved contract manufacturers site.
Current openFDA PMA Record#
- Device
- Optune System
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S023
- Product code
- NZK
- Generic name
- Stimulator, low electric field, tumor treatment
- Decision date
- 2020-03-15
- Decision code
- OK30
- Date received
- 2020-02-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Move certain assembly activities performed for the Optune System from one building to another at the approved contract manufacturers site.