|
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 | S004 |
Date Received | 04/29/2014 |
Decision Date | 10/22/2015 |
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 A CHANGE IN THE CART HIGH POTENTIAL (HI-POT) BREAKDOWN TEST SEQUENCE AND THE RELEASE OF HAND-HELD IMAGER HI-POT BREAKDOWN TEST PROCEDURE. |