Nevisense
FDA premarket approval P150046/S003 · decided 2018-12-11
Approval details
- PMA number
- P150046
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Nevisense
- Generic name
- Electrical Impedance Spectrometer
- Applicant
- Scibase AB
- Date received
- 2018-11-21
- Decision date
- 2018-12-11
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- ONV
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Stockholm
- Statement
- Relocation of component contract manufacturer, Kitron ab, which manufactures the following major components of the Nevisense Device: Control Unit, Probe Unit, and Test Impedance Tools.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.