PMA P100034S030
- Device
- Optune
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S030
- Product code
- NZK
- Decision date
- 2024-01-16
- Classification
- Neurology
- Generic name
- Stimulator, low electric field, tumor treatment
- Approval order statement
- approval for the MAXPOINT BR-I (“MAXPOINT”) Optune transducer array layout software
Current openFDA PMA Record#
- Device
- Optune
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S030
- Product code
- NZK
- Generic name
- Stimulator, low electric field, tumor treatment
- Decision date
- 2024-01-16
- Decision code
- APPR
- Date received
- 2023-01-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the MAXPOINT BR-I (“MAXPOINT”) Optune transducer array layout software