Nevisense
FDA premarket approval P150046/S001 · decided 2018-07-13
Approval details
- PMA number
- P150046
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Nevisense
- Generic name
- Electrical Impedance Spectrometer
- Applicant
- Scibase AB
- Date received
- 2018-05-09
- Decision date
- 2018-07-13
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- ONV
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Stockholm
- Statement
- Approval for addition of a patient labeling for the Nevisense Device.
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