Physio-Control Lifepak 11 defibrillator/pacer 510(k) pending at FDA -- IPO prospectus.
This article was originally published in The Gray Sheet
Executive Summary
PHYSIO-CONTROL LIFEPAK 11 DEFIBRILLATOR/PACEMAKER 510(K) PENDING at FDA, the company says in a preliminary prospectus for an initial public offering. The advanced life support system, designed for use with Physio-Control's Lifepak 11 vital signs monitor, "provides for defibrillation and pacing together with 12-lead diagnostic assessment capabilities to diagnose myocardial infarction in the out-of-hospital environment," according to the company.