FDA Allows Defibrillator Maker to Resume Shipments
February 22, 2010 – The FDA said Physio‐Control Inc. has improved the quality of its external defibrillators and may resume unrestricted worldwide shipments.
In May 2008, Physio‐Control signed a consent decree with the FDA to address issues the agency raised during inspections of the company’s quality system. Under the terms of this agreement, Physio‐Control was permitted to ship a limited number of products to emergency care providers to meet public health and safety needs until quality system improvements were completed.
During the past two years, Physio‐Control received FDA 510(k) clearance of the LIFEPAK 15 monitor/defibrillator, the LIFEPAK 20e defibrillator/monitor and the LIFENET System Version 4.1, the latest update of its Web‐based platform for capturing and sharing emergent STEMI patient data. The company also introduced a new battery‐operated version of the LUCAS Chest Compression System, a portable, easy‐to‐use device that delivers automated chest compressions to improve blood flow in victims of cardiac arrest.
For more information: www.physio‐control.com