Optune
FDA premarket approval P100034/S032 · decided 2024-02-02
Approval details
- PMA number
- P100034
- Supplement
- S032
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Optune
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2023-07-25
- Decision date
- 2024-02-02
- Days to decision
- 192 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- 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.
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