Medtronic, Inc.; Premarket Approval of the CapSureRegister Epi Pacing Lead, Model 4965

Streszczenie

The Food and Drug Administration (FDA) is announcing its approval of the application submitted by Medtronic, Inc., Minneapolis, MN, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the CapSure Epi Pacing Lead, Model 4965. 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 September 6, 1996, of the approval of the application.