Paragonix Technologies Inc. Announces Filing of a 510(k) Pre-Marketing Notification Application With the FDA for the Paragonix Sherpa Cardiac Transport System
Published: Nov 06, 2012
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Paragonix Technologies, Inc. today announced that it has successfully completed filing of a Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) for its Paragonix Sherpa Pak™ Cardiac Transport System1,2(CTS). The Sherpa Pak CTS is indicated for the static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with the heart.