PMA P100034S002

Device: NOVOTTF-100A SYSTEM
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S002
Product code: NZK
Decision date: 2012-12-03
Generic name: Stimulator, low electric field, tumor treatment
Approval order statement: APPROVAL FOR MODIFICATION TO THE FIELD GENERATOR COMPONENT OF THENOVOTTF-L00A SYSTEM TO REPLACE PIN: DAC7614E WITH PIN: 2IC-103572, AND CORRESPONDING CHANGES TO THE ASSOCIATED RESISTORS AND CAPACITORS TO LIMIT THE PART VOLTAGE RANGE AND ELIMINATE AN OBSERVED CURRENT SPIKE. CORRESPONDING SOFTWARE CHANGES WERE ALSO MADE TO REFLECT THESEMODIFICATIONS.

Current openFDA PMA Record#

Device: NOVOTTF-100A SYSTEM
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S002
Product code: NZK
Generic name: Stimulator, low electric field, tumor treatment
Decision date: 2012-12-03
Decision code: APPR
Date received: 2012-09-28
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATION TO THE FIELD GENERATOR COMPONENT OF THENOVOTTF-L00A SYSTEM TO REPLACE PIN: DAC7614E WITH PIN: 2IC-103572, AND CORRESPONDING CHANGES TO THE ASSOCIATED RESISTORS AND CAPACITORS TO LIMIT THE PART VOLTAGE RANGE AND ELIMINATE AN OBSERVED CURRENT SPIKE. CORRESPONDING SOFTWARE CHANGES WERE ALSO MADE TO REFLECT THESEMODIFICATIONS.