Guidant Corp.; Premarket Approval of SELUTERegister Steroid Eluting Endocardial Lead Models 4185 and 4285

摘要

The Food and Drug Administration (FDA) is announcing its approval of the application by Guidant Corp., St. Paul, MN, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of SELUTE Steroid Eluting Endocardial Lead Models 4185 and 4285. FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of May 8, 1996, of the approval of the application.