Urologix, Inc.; Premarket Approval of the T3Register Targeted Transurethral Thermoablation System: Model 4000

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The Food and Drug Administration (FDA) is announcing its approval of the application by Urologix, Inc., Minneapolis, MN, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the T3 Targeted Transurethral Thermoablation System: Model 4000. FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of August 22, 1997, of the approval of the application.