PMA P100034S010

Device: OPTUNE
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S010
Product code: NZK
Decision date: 2014-09-28
Classification: Stimulator, Low Electric Field, Tumor Treatment
Generic name: Stimulator, low electric field, tumor treatment
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.

Current openFDA PMA Record#

Device: OPTUNE
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S010
Product code: NZK
Generic name: Stimulator, low electric field, tumor treatment
Decision date: 2014-09-28
Decision code: APPR
Date received: 2014-05-30
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.