PLETHORA SOLUTIONS RECEIVES 510(K) MARKETING APPROVAL FROM US FDA FOR DIAGNOSIS AND EVALUATION OF EJACULATION LATENCY USING THE SAM (PSD401) DEVICE

Plethora Solutions Holdings announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its SAM device (PSD401). The product will be used for the reproducible measurement and recording of ejaculation latency time in clinical trials and in the diagnosis, evaluation and management of patients with premature ejaculation. The product has already received CE mark approval for European marketing.

Plethora Solutions (http://www.plethorasolutions.co.uk/pdf/PlethoraSolutionsReceives510k250906.pdf)