Cardica Submits Additional Documentation to FDA in Support of 510(k) Submission
Wednesday 16 December 2015
Cardica, Inc. (Nasdaq:CRDC) today announced that it submitted its responses to the questions raised by the U.S. Food and Drug Administration (FDA) on Cardica’s 510(k) submission for an expanded Indication for Use for the MicroCutter XCHANGE® 30. The responses to the FDA included the results from Cardica’s new chronic animal study conducted specifically in response to one of the FDA’s questions.
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