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.
Approval for changes to the test procedures for the hand held cart assembly; deployment of new software and installation workstations and an update for the hand held test method.
| Device | MELAFIND |
| Classification Name | Optical Diagnostic Device For Melanoma Detection |
| Generic Name | Optical Diagnostic Device For Melanoma Detection |
| Applicant | STRATA SKIN SCIENCES, INC. |
| Date Received | 2014-04-29 |
| Decision Date | 2015-01-26 |
| PMA | P090012 |
| Supplement | S008 |
| Product Code | OYD |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | STRATA SKIN SCIENCES, INC. 100 Lakeside Dr Ste 100 horsham, PA 19044 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P090012 | Original 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 |