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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 NumberS007
Date Received04/29/2014
Decision Date11/26/2014
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 THE CHANGES LISTED BELOW:1) INITIAL RELEASE OF USB 2.0 FOR HAND-HELD IMAGER; 2) REDESIGNED CARD READER ASSEMBLY; 3) RELEASED ACCESSORY KIT WITH DIGITAL CAMERA; 4) HIGH CAPACITY CARD OPTION ADDED; AND 5) MODIFIED PHANTOM FIXTURE MECHANICAL TOLERANCES.
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