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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceNEVISENSE
Generic NameElectrical Impedance Spectrometer
ApplicantSCIBASE AB
KAMMAKARGATAN 22
STOCKHOLM SE-11-1140
PMA NumberP150046
Date Received12/07/2015
Decision Date06/28/2017
Product Code ONV 
Docket Number 17M-3982
Notice Date 06/30/2017
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT01077050
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Nevisense. This device is indicated for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma, when a dermatologist chooses to obtain additional information when considering biopsy. Nevisense should not be used on clinically obvious melanoma. The Nevisense result is one element of the overall clinical assessment. The output of Nevisense should be used in combination with clinical and historical signs of melanoma to obtain additional information prior to a decision to biopsy. Nevisense is indicated only for use on: primary skin lesions with a diameter between 2 mm and 20 mm; lesions that are accessible by the Nevisense probe; lesions where the skin is intact (i.e., non-ulcerated or non-bleeding lesions); lesions that do not contain a scar or fibrosis consistent with previous trauma; lesions not located in areas of psoriasis, eczema, acute sunburn, or similar skin conditions; lesions not in hair-covered areas; lesions which do not contain foreign matter; lesions not on special anatomic sites (i.e., not for use on acral skin, genitalia, eyes, mucosal areas).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 S003 S004 
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