REDMOND, Washington — After clearing up concerns about its quality control procedures, Medtronic subsidiary Physio-Control Inc. has been approved by the Food and Drug Administration to resume worldwide shipments of its automated external defibrillators.
The move ends three years of headaches for Physio-Control, which voluntarily suspended shipments in January 2007. In May 2008, the company signed a consent decree with the FDA in which Physio-Control agreed to limit sales to only emergency providers, according to a statement from Medtronic.
“We dedicated significant energy and resources to establishing a new operating standard for our quality system and we are pleased it has met with the FDA’s approval,” said Brian Webster, Physio-Control’s president.
The problems with the FDA prevented Medtronic from moving forward with a planned spin-off of Physio-Control. Medtronic said in December that the spin-off was on hold until at least the end of fiscal 2010, the Seattle Times reported.
Automated external defibrillators are computerized medical devices that check a patient’s heart rhythm and are capable of delivering an electronic shock to correct an irregular rhythm. They’re available over the counter and are often kept in emergency services vehicles, airports and other public places.
Physio-Control says it “pioneered” defibrillation technology 55 years ago.
Physio-Control had sales of $192 million and pretax income of $5 million in the six months ended Oct. 24, compared with $169 million in sales and a $17 million loss in the year-earlier period, the Times reported.
