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.

DeviceNevisense
Generic NameElectrical Impedance Spectrometer
ApplicantSCIBASE AB
Date Received2019-05-31
Decision Date2020-04-30
PMAP150046
SupplementS004
Product CodeONV 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address SCIBASE AB kammakargatan 22 stockholm SE-11-1140

Supplemental Filings

Supplement NumberDateSupplement Type
P150046Original 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 IDPMASupp
07350094440217 P150046 000
07350094440200 P150046 000
07350094440194 P150046 000
07350094440101 P150046 000
07350094440095 P150046 000
07350094440088 P150046 000
07350094440071 P150046 000
07350094440279 P150046 002

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