This article was originally published in The Gray Sheet
File a premarket approval application with FDA for the Urolase side-firing laser for the treatment of benign prostatic hyperplasia, Trimedyne announces July 26. Patients in the six-center randomized, controlled PMA study were followed for one year. The firms' submission comes on the heels of a July FDA announcement that PMAs will be required for the devices ("The Gray Sheet" July 5, In Brief).
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