FDA Panel To Review Medtronic’s Chronicle Heart Failure Monitor March 1
This article was originally published in The Gray Sheet
Executive Summary
FDA's Circulatory System Devices Panel will consider Medtronic's PMA for the Chronicle continuous cardiac monitor for congestive heart failure patients at its March 1 meeting in Gaithersburg, Md
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Correction
In the Feb. 26 issue of "The Gray Sheet," a story switched the names of Medtronic's and St. Jude Medical's remote patient monitoring networks (1"The Gray Sheet" Feb. 26, 2007, p. 5). Medtronic's network is dubbed Medtronic CareLink Network and St. Jude's is called HouseCall Plus...
Panel Votes Against Medtronic’s Chronicle, Offers Ideas For New Trial
FDA's Circulatory System Devices Panel offered Medtronic advice on how to design a new trial for its Chronicle implantable hemodymanic monitor after voting against approval of the product's PMA