Medtronic Unit Reaches Deal With FDA

Law360 (April 28, 2008, 12:00 AM EDT) -- Medtronic Inc. subsidiary Physio-Control said Monday it had brokered a deal with the U.S. Food and Drug Administration over how to improve quality problems related to its external defibrillators more than one year after the company was forced to halt U.S. shipments of the products.

Physio-Control said it had reached an agreement with the FDA on a consent decree that addresses issues raised by the agency during inspections regarding the company’s quality system processes.

The consent decree outlines the actions it must take in order to...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.