PMA P100034S003
- Device
- NOVOTTF-100A SYSTEM
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S003
- Product code
- NZK
- Decision date
- 2013-04-17
- Classification
- Stimulator, Low Electric Field, Tumor Treatment
- Generic name
- Stimulator, low electric field, tumor treatment
- Approval order statement
- APPROVAL FOR SOFTWARE MODIFICATION TO ADD AN ALARM TO THE IDLE LOOP (THE NON-TREATMENT LOOP) TO INDICATE THAT THE DEVICE IS STILL POWERED ON EVEN WHEN TREATMENT IS NOT ACTIVE.
Current openFDA PMA Record#
- Device
- NOVOTTF-100A SYSTEM
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S003
- Product code
- NZK
- Generic name
- Stimulator, low electric field, tumor treatment
- Decision date
- 2013-04-17
- Decision code
- APPR
- Date received
- 2013-01-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SOFTWARE MODIFICATION TO ADD AN ALARM TO THE IDLE LOOP (THE NON-TREATMENT LOOP) TO INDICATE THAT THE DEVICE IS STILL POWERED ON EVEN WHEN TREATMENT IS NOT ACTIVE.