PMA P100034S019

Device

Optune System

Applicant

Novocure, GmbH

PMA number

P100034

Supplement

S019

Product code

NZK

Decision date

2018-12-19

Classification

Stimulator, Low Electric Field, Tumor Treatment

Generic name

Stimulator, low electric field, tumor treatment

Approval order statement

Approval for changes to Optune System carrying case and INE Transducer Array package sizes; Optune System software modifications increasing the secondary alarm threshold for INE Transducer Array partial attachment, correcting data transfer processing following switch from battery to mains power, and eliminating a redundant INE Transducer Array overheating alarm; and NovoTerminal software modifications improving Optune System data transfer processing.

Summary

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