|
Device | MELAFIND |
Generic Name | Optical diagnostic device for melanoma detection |
Applicant | STRATA SKIN SCIENCES, INC. 100 LAKESIDE DR STE 100 Horsham, PA 19044 |
PMA Number | P090012 |
Supplement Number | S006 |
Date Received | 04/29/2014 |
Decision Date | 01/12/2016 |
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 Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE FOLLOWING CHANGES:1) CHANGES TO THE TOLERANCES IN THE COMPUTER MOUNT AND SWITCH BRACKET;2) RELOCATION OF MOUNTING HOLES ON THE COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) PRINTED CIRCUIT BOARD (PCB); 3) OPTIMIZATION OF POWER SUPPLY CAPACITORS AND ADDITION OF RESISTOR VALUES TO TEST SET; AND; 3) CHANGES TO COMPUTER LED INDICATOR AND ASSOCIATED WIRING. |