NEVISENSE
FDA premarket approval P150046 · decided 2017-06-28
Approval details
- PMA number
- P150046
- Trade name
- NEVISENSE
- Generic name
- Electrical Impedance Spectrometer
- Applicant
- Scibase AB
- Date received
- 2015-12-07
- Decision date
- 2017-06-28
- Days to decision
- 569 days
- Decision code
- APRL
- Product code
- ONV
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Stockholm
- Statement
- Approval for the Nevisense. This device is indicated for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma, when a dermatologist chooses to obtain additional information when considering biopsy. Nevisense should not be used on clinically obvious melanoma. The Nevisense result is one element of the overall clinical assessment. The output of Nevisense should be used in combination with clinical and historical signs of melanoma to obtain additional informa
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