Zdrowie i gospodarka · 15/12/1994

Endosonics Corp.; Premarket Approval of the Endosonics OracleSUPTM Micro PTCA Catheter

The Food and Drug Administration (FDA) is announcing its approval of the application by Endosonics Corp., Rancho Cordova, CA, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Endosonics Oracle TM Micro PTCA Catheter. 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 September 30, 1994, of the approval of the application.