Trimedyne/Bard submits 510(k) for Urolase BPH indication per FDA policy change.
This article was originally published in The Gray Sheet
Executive Summary
TRIMEDYNE/BARD UROLASE FOR BPH: 510(K) HAS BEEN SUBMITTED to FDA, Bard says. The submission was filed in the wake of a recent change in FDA policy that allows laser manufacturers to use 510(k)s with "limited confirmatory data" to seek clearance for labeling indications for the treatment of benign prostatic hyperplasia. Trimedyne's 510(k) is supported by data from an already pending premarket approval application, according to Bard.