In Brief: Urologix T3
This article was originally published in The Gray Sheet
Executive Summary
Urologix T3: Premarket approval application for targeted transurethral thermo-ablation system is accepted for filing by FDA, Urologix states. The PMA for the device, intended for treatment of benign prostatic hyperplasia without the use of anesthesia, was submitted in March ("The Gray Sheet" March 17, In Brief). FDA has indicated to Urologix that the T3 will not be referred to an FDA advisory panel for review...