PMA P100034S029

Device: Optune® device
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S029
Product code: NZK
Decision date: 2022-05-10
Generic name: Stimulator, low electric field, tumor treatment
Approval order statement: Approval for changes to the specifications of the ceramic discs used in the INE Transducer Arrays to make them lead-free, and the addition of a new supplier for these lead-free ceramic discs, Vishay Electronics GmbH, located at Dr.-Felix-Zandman-Platz 1, Selb 95100, Germany.

Current openFDA PMA Record#

Device: Optune® device
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S029
Product code: NZK
Generic name: Stimulator, low electric field, tumor treatment
Decision date: 2022-05-10
Decision code: APPR
Date received: 2022-02-14
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for changes to the specifications of the ceramic discs used in the INE Transducer Arrays to make them lead-free, and the addition of a new supplier for these lead-free ceramic discs, Vishay Electronics GmbH, located at Dr.-Felix-Zandman-Platz 1, Selb 95100, Germany.