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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 NumberS003
Date Received11/21/2018
Decision Date12/11/2018
Reclassified Date04/24/2026
Product Code ONV 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order 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.
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