Medtronic unit agrees with FDA on defibrillator quality

MINNEAPOLIS—Medical device maker Medtronic Inc. said Monday its Physio-Control Inc. subsidiary reached an agreement with the Food and Drug Administration on quality improvements for its external defibrillators.

The agreement addresses issues raised by the FDA during inspections and lists actions Physio-Control must take to resume unrestricted distribution of its external defibrillators.

Last year, Medtronic put off plans to spin off Physio-Control after shipments of external defibrillators were delayed because of unspecified quality problems.

Physio-Control said the agreement was filed Friday in United States District Court for the Western District of Washington.

"During the last year, we've made significant investments and improvements to our quality systems and we are pleased to have a plan that formalizes the path to resume full distribution," Physio-Control President Brian Webster said in a statement.