FDA lifts final warning letters for AngioDynamics

AngioDynamics (NSDQ:ANGO) said today that the FDA closed out a pair of warning letters sent in 2011 and 2014, closing the book on all warning letters sent to the Latham, N.Y.-based medical device company.

The federal safety watchdog last month resolved another warning letter sent to AngioDynamics in January 2011 over the NanoKnife tissue ablation device.

AngioDynamics said the FDA also closed out a November 2014 letter sent after the agency received 55 complaints alleging the presence of hair in long-term-use catheter packaging. The bureau also closed out a May 2011 letter flagging problems with its Centros chronic hemodialysis catheter.

“The removal of the final warning letters is a reflection of the exceptional quality and operations teams we have today at AngioDynamics. Over the past 4 years, they have worked diligently with the FDA to fully address the issues and help to instill a culture within the company that is committed to quality and compliance,” president & CEO Joseph DeVivo said in prepared remarks. “The resolution of these issues is a significant boost to AngioDynamics and improves our ability to drive the growth of the business, especially in international markets.”

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