The FDA has granted clearance to Physio-Control, a subsidiary of Medtronic, for unrestricted worldwide distribution of its Lifepak external defibrillator.
In 2008, the company signed a consent decree with the FDA to address issues regarding the inspection of its quality system, according to Redmond, Wash.-based Physio-Control.
Under the decree, the FDA issued that Physio-Control could ship a limited number of its defibrillators to emergency care providers in order to meet patient health needs until the quality initiative improvements were completed.
The Lifepak external defibrillator is indicated for use to treat sudden cardiac arrest. Physio-Control’s Lifepak 15 monitor/defibrillator and the Lifepak 20e defibrillator/monitor both received FDA 510(k) clearance within the past two years.