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
Generic Name	Stimulator, low electric field, tumor treatment
Applicant	Novocure, GmbH Neuhofstrasse 21 Baar 6340
PMA Number	P100034
Supplement Number	S010
Date Received	05/30/2014
Decision Date	09/28/2014
Product Code	NZK
Advisory Committee	Neurology
Supplement Type	Normal 180 Day Track No User Fee
Supplement Reason	Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted?	No
Combination Product	No
Predetermined Change Control Plan Authorized	No
Approval Order Statement   APPROVAL FOR A TRADE NAME CHANGE FROM THE NOVOTTF-100A SYSTEM TO OPTUNE¿. YOU HAVE ALSO REQUESTED THAT THE COMPONENTS OF THE NOVOTTF-100A SYSTEM (A PLUGIN POWER SUPPLY; CHARGER FOR PORTABLE BATTERIES; DEVICE & BATTERY CARRYING BAG; PORTABLE BATTERY; AND, CONNECTION CABLE & BOX), ALONG WITH THE TRANSDUCER ARRAY AND ELECTRIC FIELD GENERATOR (THE DEVICE), BE NAMED THE OPTUNE¿ TREATMENT KIT.