Medtronic, Inc.; Premarket Approval of the MedtronicRegister TransveneRegister Lead System

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The Food and Drug Administration (FDA) is announcing its approval of the application by Medtronic, Inc., Minneapolis, MN, for premarket approval, under section 515 of the Federal Food, Drug, and Cosmetic Act (the act), of the Medtronic Transvene Lead System. After reviewing the recommendation of the Circulatory System Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of December 9, 1993, of the approval of the application.