ENPATH MEDICAL PROVIDES UPDATE ON MYOPORE RX STEROID LEAD STATUS WITH FDA

Enpath Medical has reported that the FDA requested more clinical data regarding the company's Myopore Rx steroid lead before the agency will consider the company's request for marketing clearance. The company originally filed the submission in July 2004 and had been proceeding on the understanding that the FDA would grant approval based upon the originally determined regulatory pathway of a paper premarket approval.

BioSpace (http://www.biospace.com/news_story.cfm?StoryID=18701520&full=1)