FDAnews
www.fdanews.com/articles/137006-heart-valve-rings-slip-through-fda-loophole

Heart-Valve Rings Slip Through FDA Loophole

May 23, 2011
If you have a faulty heart valve and decide to get it replaced, a surgeon will implant an artificial one that has undergone rigorous examination by the Food and Drug Administration.
WGN Radio