PMA P100034S046

Device: Optune HFE Transducer Arrays
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S046
Product code: NZK
Decision date: 2026-09-16
Classification: Neurology
Generic name: Stimulator, low electric field, tumor treatment
Approval order statement: approval to implement a minor change to the pallet configuration for the maximum load during gamma sterilization process for the HFE arrays performed at Steris Schweiz

Current openFDA PMA Record#

Device: Optune HFE Transducer Arrays
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S046
Product code: NZK
Generic name: Stimulator, low electric field, tumor treatment
Decision date: 2026-09-16
Decision code: OK30
Date received: 2026-08-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval to implement a minor change to the pallet configuration for the maximum load during gamma sterilization process for the HFE arrays performed at Steris Schweiz