Physio-Control
This article was originally published in The Gray Sheet
Executive Summary
Lifepak 300 external defibrillator reenters U.S. market. The device is the last of the Lilly subsidiary's external defibrillators to be reintroduced following withdrawal of the line in May 1992 due to medical device reporting and good manufacturing practice violations. FDA reinspected the Lifepak 300 production line in January ("The Gray Sheet" Jan. 3, p. 21)