CryoCor delays amended PMA:
This article was originally published in Clinica
CryoCor has delayed filing an amendment to the PMA application for its cryoablation system for treating atrial flutter, probably until the end on November 2006. The FDA rejected the company's original application in February of this year because it failed to meet the agency's chronic efficacy criteria (see Clinica No 1193, p 21). CryoCor originally said that it would file an amended PMA in the third quarter, but now says it needs additional time in order to provide supplementary information to the original data.
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