Biotronik, Inc. Receives FDA Approval for Dromos Cardiac Pacing Systems

Summary

The U.S. Food and Drug Administration (FDA) has approved Biotronik, Inc.'s application for premarket approval of its Dromos DR/DR-A and Dromos SR/SR-B Cardiac Pacing Systems, which will be notified to the applicant by letter on October 11, 1996, by the FDA's Center for Devices and Radiological Health (CDRH).