PMA P100034S005
- Device
- NOVA TTF-100A SYSTEM
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S005
- Product code
- NZK
- Decision date
- 2013-06-12
- Generic name
- Stimulator, low electric field, tumor treatment
- Approval order statement
- MANUFACTURING CHANGE TO THE INE TRANSDUCER ARRAY CABLE AND FLEXIBLE PRINTED CIRCUIT BOARD (PCB) OF THE DEVICE.
Current openFDA PMA Record#
- Device
- NOVA TTF-100A SYSTEM
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S005
- Product code
- NZK
- Generic name
- Stimulator, low electric field, tumor treatment
- Decision date
- 2013-06-12
- Decision code
- OK30
- Date received
- 2013-05-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MANUFACTURING CHANGE TO THE INE TRANSDUCER ARRAY CABLE AND FLEXIBLE PRINTED CIRCUIT BOARD (PCB) OF THE DEVICE.