Nevisense

FDA Premarket Approval P150046 S004

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

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.

• Device: Nevisense
• Generic Name: Electrical Impedance Spectrometer
• Applicant: SCIBASE AB
• Date Received: 2019-05-31
• Decision Date: 2020-04-30
• PMA: P150046
• Supplement: S004
• Product Code: ONV
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: SCIBASE AB kammakargatan 22 stockholm SE-11-1140

Supplemental Filings

Supplement Number	Date	Supplement Type
P150046		Original Filing
S004	2019-05-31	Normal 180 Day Track
S003	2018-11-21	30-day Notice
S002	2018-07-06	Normal 180 Day Track
S001	2018-05-09	Real-time Process

NIH GUDID Devices

Device ID	PMA	Supp
07350094440217	P150046	000
07350094440200	P150046	000
07350094440194	P150046	000
07350094440101	P150046	000
07350094440095	P150046	000
07350094440088	P150046	000
07350094440071	P150046	000
07350094440279	P150046	002