PMA P100034S028

Device: Optune System
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S028
Product code: NZK
Decision date: 2021-05-24
Generic name: Stimulator, low electric field, tumor treatment
Approval order statement: Approval for a manufacturing site, Synergy Health Däniken AG (Steris), located at Hogenweidstrasse 6, CH-4658, Daniken, Switzerland. This site is a sterilization facility used to sterilize the INE Transducer Arrays in the Optune System.

Current openFDA PMA Record#

Device: Optune System
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S028
Product code: NZK
Generic name: Stimulator, low electric field, tumor treatment
Decision date: 2021-05-24
Decision code: APPR
Date received: 2021-03-22
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, Synergy Health Däniken AG (Steris), located at Hogenweidstrasse 6, CH-4658, Daniken, Switzerland. This site is a sterilization facility used to sterilize the INE Transducer Arrays in the Optune System.