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Business · 02/07/1997

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

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).

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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