PMA P100034S032

Device: Optune
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S032
Product code: NZK
Decision date: 2024-02-02
Classification: Neurology
Generic name: Stimulator, low electric field, tumor treatment
Approval order statement: approval for a manufacturing site located at United States (U.S.) Operation Center II (USOC II), Novocure Inc., 2555 USA Parkway, Suite 104A, Sparks, Nevada 89437, that will perform the activities of receipt, cleaning, acceptance, storage, service, packaging, labeling and release for distribution of the Optune treatment kit.

Current openFDA PMA Record#

Device: Optune
Applicant: Novocure, GmbH
PMA number: P100034
Supplement: S032
Product code: NZK
Generic name: Stimulator, low electric field, tumor treatment
Decision date: 2024-02-02
Decision code: APPR
Date received: 2023-07-25
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 located at United States (U.S.) Operation Center II (USOC II), Novocure Inc., 2555 USA Parkway, Suite 104A, Sparks, Nevada 89437, that will perform the activities of receipt, cleaning, acceptance, storage, service, packaging, labeling and release for distribution of the Optune treatment kit.