Cardiac Pacemakers, Inc.; Premarket Approval of the 0060 Series ENDOTAKRegister Lead System

Streszczenie

The Food and Drug Administration (FDA) is announcing its approval of the application by Cardiac Pacemakers, Inc., St. Paul, MN, for premarket approval, under section 515 of the Federal Food, Drug, and Cosmetic Act (the act), of the 0060 Series ENDOTAK Lead System (the ENDOTAK 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 August 26, 1993, of the approval of the application.