Bard Vascular Systems Division, C. R. Bard, Inc.; Premarket Approval of BardRegister Albumin Coated DeBakeyRegister VasculourRegister-II Vascular Prosthesis

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The Food and Drug Administration (FDA) is announcing its approval of the application by C. R. Bard, Inc., Billerica, MA, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of Bard Albumin Coated DeBakey Vasculour -II Vascular Prosthesis. FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter on October 21, 1994, of the approval of the application.