PMA P100034S004
- Device
- NOVOTTF-100A SYSTEM
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S004
- Product code
- NZK
- Decision date
- 2013-08-08
- Classification
- Stimulator, Low Electric Field, Tumor Treatment
- Generic name
- Stimulator, low electric field, tumor treatment
- Approval order statement
- APPROVAL FOR TRANSFERRING THE RESPONSIBILITY OF PERFORMING THE NOVOTAL TRANSDUCER ARRAY MAPPING FROM NOVOCURES STAFF TO TRAINED PHYSICIANS RESPONSIBLE FOR PRESCRIBING THE DEVICE.
Current openFDA PMA Record#
- Device
- NOVOTTF-100A SYSTEM
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S004
- Product code
- NZK
- Generic name
- Stimulator, low electric field, tumor treatment
- Decision date
- 2013-08-08
- Decision code
- APPR
- Date received
- 2013-04-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR TRANSFERRING THE RESPONSIBILITY OF PERFORMING THE NOVOTAL TRANSDUCER ARRAY MAPPING FROM NOVOCURES STAFF TO TRAINED PHYSICIANS RESPONSIBLE FOR PRESCRIBING THE DEVICE.