Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: NOVOCURE NOVOTTF-100A SYSTEM
• Classification Name: stimulator, low electric field, tumor treatment
• Applicant: NOVOCURE, LTD.
• PMA Number: P100034
• Supplement Number: S001
• Date Received: 05/04/2011
• Decision Date: 01/03/2012
• Product Code: NZK [ Registered Establishments with NZK ]
• Advisory Committee: Ophthalmic
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: postapproval protocol or modification to a protocol
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval of the post-approval study protocol.