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.
Added 3rd party operating system installation software to version registry; and deployment of new software build and installation workstations.
| 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 | 2014-07-07 |
| PMA | P090012 |
| Supplement | S009 |
| Product Code | OYD |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 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 |