IRVINE, Calif. (AP) -- Heart device maker Edwards Lifesciences Corp. said Tuesday it has received a warning letter from the Food and Drug Administration that stems from a September inspection of a company location.
The Irvine, Calif., company said the letter focused on six incidents of late medical device reporting. Edwards did not offer more details but said it has since corrected its training procedures on the medical device reporting process and it "does not expect this matter to have any impact on product approvals."
Shares of the company fell 98 cents to $102.22 in Tuesday afternoon trading.
