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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.
 
DeviceMELAFIND
Generic NameOptical diagnostic device for melanoma detection
Regulation Number878.1820
ApplicantStrata Skin Sciences, Inc.
100 Lakeside Dr. Suite 100
Horsham, PA 19044
PMA NumberP090012
Supplement NumberS011
Date Received06/11/2015
Decision Date08/18/2016
Reclassified Date04/24/2026
Product Code OYD 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT00434057
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for changing your calibration validation self-test method from the Field Phantom Imaging Self-Test to the Flap Shutter Self-Test.
Post-Approval StudyShow Report Schedule and Study Progress
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