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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
ApplicantSTRATA SKIN SCIENCES, INC.
100 LAKESIDE DR STE 100
Horsham, PA 19044
PMA NumberP090012
Supplement NumberS002
Date Received08/13/2012
Decision Date10/02/2012
Product Code OYD 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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