Physio-Control receives US clearance for Lifepak 15
8 April 2009
Physio-Control, Inc., a wholly owned subsidiary of Medtronic, (NYSE:
MDT) has received clearance from the US FDA to market the LIFEPAK 15
monitor/defibrillator within the United States.
“With the LIFEPAK 15 monitor/defibrillator, Physio-Control is
delivering on its commitment to provide innovative, reliable and durable
equipment to emergency personnel so they can focus on the most important
task at hand — saving lives,” said Brian Webster, president of Physio-Control.
“This industry was built on the innovations delivered by Physio-Control
and the LIFEPAK 15 monitor continues to define the new standard for
emergency care products.”
With nearly 700,000 LIFEPAK defibrillators distributed worldwide, the
company is one of the world’s leading providers of external
defibrillation and monitoring technology for the treatment of sudden
cardiac arrest and other cardio-respiratory emergencies.
Physio-Control entered into a consent decree with the FDA in May,
2008. The decree currently places restrictions on the type and amount of
products which may be shipped until improvements to the company’s
quality system have been confirmed. In the interim, Physio is able to
ship a limited selection of product to meet customer needs.
Bookmark this page