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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceNevisense
Generic NameElectrical Impedance Spectrometer
Regulation Number878.1820
ApplicantScibase AB
Kammakargatan 22
Stockholm SE-1140
PMA NumberP150046
Supplement NumberS004
Date Received05/31/2019
Decision Date04/30/2020
Reclassified Date04/24/2026
Product Code ONV 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT01077050
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
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.
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