PMA P100034S021
- Device
- Optune System
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S021
- Product code
- NZK
- Decision date
- 2019-04-12
- Classification
- Stimulator, Low Electric Field, Tumor Treatment
- Generic name
- Stimulator, low electric field, tumor treatment
- Approval order statement
- Approval for an additional ceramic disc supplier with no changes to electrical specifications.
Current openFDA PMA Record#
- Device
- Optune System
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S021
- Product code
- NZK
- Generic name
- Stimulator, low electric field, tumor treatment
- Decision date
- 2019-04-12
- Decision code
- APPR
- Date received
- 2018-10-05
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an additional ceramic disc supplier with no changes to electrical specifications.