AMS Acticon Fecal Incontinence PMA Filing Is First Of Its Kind
This article was originally published in The Gray Sheet
Executive Summary
Favorable panel review of American Medical Systems' Acticon neosphincter could position the device to become the first fecal incontinence product approved via PMA application. FDA's Gastroenterology and Urology Devices Panel will review the Acticon Aug. 17 in Rockville, Maryland.