PMA P100034S035

Device: Optune System
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S035
Product code: NZK
Decision date: 2024-09-24
Classification: Neurology
Generic name: Stimulator, low electric field, tumor treatment
Approval order statement: approval to adjust the capacitance specification for the ceramic discs used in the INE Transducer Arrays. The supplement also proposed to add TDK Electronics GmbH & Co. OG (TDK), located at Siemensstrasse 43, 8530 Deutschlandsberg, Austria, as an additional supplier for the lead-free ceramic discs, so that these components may be sourced from either Vishay Electronics GmbH or TDK

Current openFDA PMA Record#

Device: Optune System
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S035
Product code: NZK
Generic name: Stimulator, low electric field, tumor treatment
Decision date: 2024-09-24
Decision code: APPR
Date received: 2024-06-26
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval to adjust the capacitance specification for the ceramic discs used in the INE Transducer Arrays. The supplement also proposed to add TDK Electronics GmbH & Co. OG (TDK), located at Siemensstrasse 43, 8530 Deutschlandsberg, Austria, as an additional supplier for the lead-free ceramic discs, so that these components may be sourced from either Vishay Electronics GmbH or TDK