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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
Applicant
STRATA SKIN SCIENCES, INC.
100 lakeside dr ste 100
horsham, PA 19044
PMA NumberP090012
Supplement NumberS004
Date Received04/29/2014
Decision Date10/22/2015
Product Code OYD 
Advisory Committee General & Plastic Surgery
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A CHANGE IN THE CART HIGH POTENTIAL (HI-POT) BREAKDOWN TEST SEQUENCE AND THE RELEASE OF HAND-HELD IMAGER HI-POT BREAKDOWN TEST PROCEDURE.
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