PMA P100034S026
- Device
- Optune System
- Applicant
- Novocure, GmbH
- Product code
- NZK
- Decision date
- 2021-07-07
- Generic name
- Stimulator, low electric field, tumor treatment
- Approval order statement
- Approval for an update of the Optune System labeling with the final post-approval study (Registry Study for Optune System) results.
Current openFDA PMA Record#
- Device
- Optune System
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S026
- Product code
- NZK
- Generic name
- Stimulator, low electric field, tumor treatment
- Decision date
- 2021-07-07
- Decision code
- APPR
- Date received
- 2021-01-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for an update of the Optune System labeling with the final post-approval study (Registry Study for Optune System) results.