PMA P100034S007

Device: NOVOTFF-100A SYSTEM
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S007
Product code: NZK
Decision date: 2014-11-12
Generic name: Stimulator, low electric field, tumor treatment
Approval order statement: APPROVAL FOR CHANGES TO THE NOVOTTF-100A INSULATED ELECTRODE (INE) TRANSDUCER ARRAY MANUFACTURING PROCESS TO IMPROVE ITS EFFICIENCY BY AUTOMATING CERTAIN MANUAL PROCESSING STEPS.

Current openFDA PMA Record#

Device: NOVOTFF-100A SYSTEM
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S007
Product code: NZK
Generic name: Stimulator, low electric field, tumor treatment
Decision date: 2014-11-12
Decision code: APPR
Date received: 2014-05-12
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGES TO THE NOVOTTF-100A INSULATED ELECTRODE (INE) TRANSDUCER ARRAY MANUFACTURING PROCESS TO IMPROVE ITS EFFICIENCY BY AUTOMATING CERTAIN MANUAL PROCESSING STEPS.