PMA P100034S016
- Device
- NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S016
- Product code
- NZK
- Decision date
- 2016-03-18
- Classification
- Stimulator, Low Electric Field, Tumor Treatment
- Generic name
- Stimulator, low electric field, tumor treatment
- Approval order statement
- Additional servicing and repair location for the Optune System.
Current openFDA PMA Record#
- Device
- NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S016
- Product code
- NZK
- Generic name
- Stimulator, low electric field, tumor treatment
- Decision date
- 2016-03-18
- Decision code
- OK30
- Date received
- 2016-02-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional servicing and repair location for the Optune System.