Nevisense
FDA premarket approval P150046/S006 · decided 2025-12-15
Approval details
- PMA number
- P150046
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Nevisense
- Generic name
- Electrical Impedance Spectrometer
- Applicant
- Scibase AB
- Date received
- 2025-12-02
- Decision date
- 2025-12-15
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- ONV
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Stockholm
- Statement
- approval for an automated electrical test station and data acquisition process for quality testing of finished disposable Nevisense electrodes, while retaining the existing manual electrical test station and process
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