Optune System
FDA premarket approval P100034/S035 · decided 2024-09-24
Approval details
- PMA number
- P100034
- Supplement
- S035
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Optune System
- Generic name
- Stimulator, low electric field, tumor treatment
- Applicant
- Novocure, GmbH
- Date received
- 2024-06-26
- Decision date
- 2024-09-24
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NZK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Baar
- Statement
- approval to adjust the capacitance specification for the ceramic discs used in the INE Transducer Arrays. The supplement also proposed to add TDK Electronics GmbH & Co. OG (TDK), located at Siemensstrasse 43, 8530 Deutschlandsberg, Austria, as an additional supplier for the lead-free ceramic discs, so that these components may be sourced from either Vishay Electronics GmbH or TDK
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.