Paragonix Technologies Inc. Announces Filing Of A Second 510(k) Pre-Marketing Notification Application With The US Food And Drug Administration For The Paragonix Sherpa™ Cardiac Transport System
Published: Nov 18, 2013
BRAINTREE, Mass.--(BUSINESS WIRE)--Paragonix Technologies, Inc. today announced that it has successfully completed filing of a second 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. The current pre-market notification application intends to further identify user indications for the static hypothermic preservation of hearts during transportation.
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