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비즈니스 · 1997. 7. 2.1 분 읽기

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

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요약

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.

원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →