PMA P100034S015
- Device
- OPTUNE
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S015
- Product code
- NZK
- Decision date
- 2016-07-13
- Classification
- Stimulator, Low Electric Field, Tumor Treatment
- Generic name
- Stimulator, low electric field, tumor treatment
- Approval order statement
- Approval for a smaller, lighter weight version of the original Optune™ System, referred to as the Optune™ System (NovoTTF-200A System).
Current openFDA PMA Record#
- Device
- OPTUNE
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S015
- Product code
- NZK
- Generic name
- Stimulator, low electric field, tumor treatment
- Decision date
- 2016-07-13
- Decision code
- APPR
- Date received
- 2015-12-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a smaller, lighter weight version of the original Optune™ System, referred to as the Optune™ System (NovoTTF-200A System).