PMA P100034S022
- Device
- Optune System
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S022
- Product code
- NZK
- Decision date
- 2019-02-28
- Classification
- Stimulator, Low Electric Field, Tumor Treatment
- Generic name
- Stimulator, low electric field, tumor treatment
- Approval order statement
- Approval for a color change to the INE Transducer Array medical tape from white to tan, and a change to the release liner of the INE Transducer Array from a paper-based material to polyester.
Current openFDA PMA Record#
- Device
- Optune System
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S022
- Product code
- NZK
- Generic name
- Stimulator, low electric field, tumor treatment
- Decision date
- 2019-02-28
- Decision code
- APPR
- Date received
- 2018-11-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a color change to the INE Transducer Array medical tape from white to tan, and a change to the release liner of the INE Transducer Array from a paper-based material to polyester.