PMA P150046S006

Device: Nevisense
Applicant: Scibase AB
PMA number: P150046
Supplement: S006
Product code: ONV
Decision date: 2025-12-15
Classification: General, Plastic Surgery
Generic name: Electrical Impedance Spectrometer
Approval order 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

Current openFDA PMA Record#

Device: Nevisense
Applicant: Scibase AB
PMA number: P150046
Supplement: S006
Product code: ONV
Generic name: Electrical Impedance Spectrometer
Decision date: 2025-12-15
Decision code: OK30
Date received: 2025-12-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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