CPI VIGOR PACEMAKER 109-PATIENT STUDY OFFERS MODEL FOR SPEEDIER APPROVALS, FDA SAYS; PANEL RECOMMENDS APPROVAL OF VIGOR, MEDTRONIC LEGEND PLUS PACERS
This article was originally published in The Gray Sheet
Cardiac Pacemakers, Inc.'s small (109-patient) premarket approval application study of its Vigor DR (dual chamber) rate responsive pacer systems provides a model for future pacemaker studies, FDA said at a Circulatory System Device Panel meeting May 9 in Gaithersburg, Maryland.
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Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.