Biotronik, Inc.; Premarket Approval of Dromos DR/DR-A and Dromos SR/SR-B Cardiac Pacing Systems

摘要

The Food and Drug Administration (FDA) is announcing its approval of the application by Biotronik, Inc., Lake Oswego, OR, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Dromos DR/DR-A and Dromos SR/SR-B Cardiac Pacing Systems. FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of October 11, 1996, of the approval of the application.