MEDTRONIC LEGEND PLUS RATE RESPONSIVE PACER WILL NOT BE MARKETED IN THE U.S. FOLLOWING PMA APPROVAL; FIRM AWAITING KAPPA 400 PACER PMA SUPPLEMENT
This article was originally published in The Gray Sheet
Executive Summary
Medtronic will not market its Legend Plus single-chamber, dual sensor, rate responsive pacer in the U.S., the firm says. Legend Plus, which gained premarket approval from FDA on Feb. 7, was one of three PMAs approved by FDA in the month of February. However, Medtronic has opted to await approval of its next-generation Kappa 400 series pacer, for which a premarket approval application supplement was submitted on Feb. 14.