AMS MALLEABLE 650, UROHEALTH DURA-II PENILE IMPLANT DOWNCLASSIFICATION SOUGHT BY HIMA; IMPLANT SILICONE MIGRATION NOT A HEALTH RISK, GROUP SAYS
This article was originally published in The Gray Sheet
Executive Summary
American Medical Systems' AMS Malleable 650 and Urohealth Systems' Dura II penile rigidity implants should be downclassified to Class II, HIMA says in a submission of data to FDA under Sec. 515(i) of device law.