American Medical Systems Inc.; Premarket Approval of the UroLumeSUPTM/SUP Endourethral Prostatic for Prostatic Obstruction Secondary to Benign Prostatic Hypertrophy

Streszczenie

The Food and Drug Administration (FDA) is announcing its approval of the application by American Medical Systems Inc., Minnetonka, MN, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the UroLume TM Endourethral Prostatic for Prostatic Obstruction Secondary to Benign Prostatic Hypertrophy (BPH). After reviewing the recommendation of the Gastroenterology-Urology Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of April 11, 1997, of the approval of the application.