Nevisense
FDA premarket approval P150046/S004 · decided 2020-04-30
Approval details
- PMA number
- P150046
- Supplement
- S004
- 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
- 2019-05-31
- Decision date
- 2020-04-30
- Days to decision
- 335 days
- Decision code
- APPR
- Product code
- ONV
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Stockholm
- Statement
- Approval for software changes to remove the reference measurement step from the device operation, introducing an in-device qualification module and lesion feedback mechanism to detect potential user errors.
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