PMA P100034S017
- Device
- Novocure Ltd.'s Optune
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S017
- Product code
- NZK
- Decision date
- 2017-03-15
- Generic name
- Stimulator, low electric field, tumor treatment
- Approval order statement
- Addition of two second source component suppliers related to the INE transducer array subassembly as well as automation of a related soldering procedure.
Current openFDA PMA Record#
- Device
- Novocure Ltd.'s Optune
- Applicant
- Novocure, GmbH
- PMA number
- P100034
- Supplement
- S017
- Product code
- NZK
- Generic name
- Stimulator, low electric field, tumor treatment
- Decision date
- 2017-03-15
- Decision code
- OK30
- Date received
- 2017-02-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of two second source component suppliers related to the INE transducer array subassembly as well as automation of a related soldering procedure.