Medtronic defibrillator label warning on cellular phone use approved by FDA.
This article was originally published in The Gray Sheet
Executive Summary
MEDTRONIC DEFIBRILLATOR WARNING LABEL ON USE OF CELLULAR PHONES was approved by FDA on April 27. The premarket approval application supplement, which covers the company's PCD and Jewel implantable cardioverter defibrillators, establishes labeling that cautions against use of cellular phones in close proximity to the devices. Similar information already is contained in patient user manuals, Medtronic said.