Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Optune System
• Generic Name: Stimulator, low electric field, tumor treatment
• Applicant: Novocure GmbH; Park 6; CH-6039 Root D4
• PMA Number: P100034
• Supplement Number: S020
• Date Received: 09/20/2018
• Decision Date: 10/19/2018
• Product Code: NZK
• Advisory Committee: Neurology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
Change to lead-free solder.