Plethora gets FDA marketing approval for urology device

By Elaine Rigoli

Tampa, Fla., Sept. 25 - Plethora Solutions Holdings plc said it has received 510(k) clearance from the Food and Drug Administration 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.

Ultimately, it is anticipated that the SAM device will be used more widely in urology clinics for general evaluation and management, according to a news release.

To pursue this objective, the London specialty pharmaceutical company said it will continue to generate additional clinical data over the next six months that will be used to obtain coding in the United States for reimbursement as a diagnostic procedure.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.