Nevisense
FDA premarket approval P150046/S002 · decided 2019-01-14
Approval details
- PMA number
- P150046
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Nevisense
- Generic name
- Electrical Impedance Spectrometer
- Applicant
- Scibase AB
- Date received
- 2018-07-06
- Decision date
- 2019-01-14
- Days to decision
- 192 days
- Decision code
- APPR
- Product code
- ONV
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Stockholm
- Statement
- Approval for hardware and software modifications including replacement of discontinued PC board and associated HW and SW changes; addition of radio module; LVDS ferrite bead replacement; new cells for rechargeable battery and reprogrammed battery safety circuit; replacement of speaker; software updates to adapt to new platform; NeviFile software; Quick Measurement function; reference measurement feedback dialogs.
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