Medtronic's Transvene
This article was originally published in The Gray Sheet
Executive Summary
FDA has notified the firm that the transvenous lead system is "approvable," Medtronic announced Sept. 29. The device, which is used in conjunction with the company's PCD third-generation implantable pacer-cardioverter-defibrillator, was recommended for approval by FDA's circulatory system devices panel on Aug. 2 ("The Gray Sheet" Aug. 9, p. 1).