TCI SEEKS TRACKING EXEMPTION FOR HEARTMATE LVAS
This article was originally published in The Gray Sheet
Executive SummaryTCI SEEKS TRACKING EXEMPTION FOR HEARTMATE LVAS in a July 29 petition to FDA. The current indication for use of the implantable pneumatic left ventricular assist system (IP LVAS) as a temporary device to be used only in a hospital setting, Thermo Cardiosystems Inc. argues, should allow it to be exempted from medical device tracking requirements.
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