www.fdanews.com/articles/167798-fda-panel-engineered-donor-heart-valves-need-pma
FDA Panel: Engineered Donor Heart Valves Need PMA
October 13, 2014
An FDA advisory committee has recommended that "more than minimally manipulated" (MMM) allograft heart valves, which currently lack a clear classification, should be regulated as high-risk devices.
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