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.

Generic NameElectrical Impedance Spectrometer
Date Received2019-05-31
Decision Date2020-04-30
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


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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