MELAFIND

Optical Diagnostic Device For Melanoma Detection

FDA Premarket Approval P090012 S002

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.

Pre-market Approval Supplement Details

Approval of the post-approval study protocol.

DeviceMELAFIND
Classification NameOptical Diagnostic Device For Melanoma Detection
Generic NameOptical Diagnostic Device For Melanoma Detection
ApplicantSTRATA SKIN SCIENCES, INC.
Date Received2012-08-13
Decision Date2012-10-02
PMAP090012
SupplementS002
Product CodeOYD
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Osb
Expedited ReviewNo
Combination Product No
Applicant Address STRATA SKIN SCIENCES, INC. 100 Lakeside Dr Ste 100 horsham, PA 19044

Supplemental Filings

Supplement NumberDateSupplement Type
P090012Original Filing
S011 2015-06-11 Normal 180 Day Track
S010 2014-06-17 Normal 180 Day Track
S009 2014-04-29 30-day Notice
S008 2014-04-29 135 Review Track For 30-day Notice
S007 2014-04-29 135 Review Track For 30-day Notice
S006 2014-04-29 135 Review Track For 30-day Notice
S005 2014-04-29 135 Review Track For 30-day Notice
S004 2014-04-29 135 Review Track For 30-day Notice
S003 2014-02-12 Normal 180 Day Track No User Fee
S002 2012-08-13 Normal 180 Day Track No User Fee
S001 2011-11-01 Normal 180 Day Track No User Fee

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