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 of the post-approval study protocol.
| 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 | 2012-08-13 |
| Decision Date | 2012-10-02 |
| PMA | P090012 |
| Supplement | S002 |
| Product Code | OYD |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Osb |
| 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 |