PMA P100034S027

Device: Optune System
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S027
Product code: NZK
Decision date: 2021-03-09
Generic name: Stimulator, low electric field, tumor treatment
Approval order statement: Approval for a manufacturing site, A.L. Electronics LTD, located at 24 Giron Abraham Street, Yehud, Israel 56217, to manufacture the INE Transducer Arrays in the Optune System.

Current openFDA PMA Record#

Device: Optune System
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S027
Product code: NZK
Generic name: Stimulator, low electric field, tumor treatment
Decision date: 2021-03-09
Decision code: APPR
Date received: 2021-01-08
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site, A.L. Electronics LTD, located at 24 Giron Abraham Street, Yehud, Israel 56217, to manufacture the INE Transducer Arrays in the Optune System.