MiCardia Corporation

MiCardia Corporation Receives US FDA Market Clearance for Dynaplasty Annuloplasty Devices

Published in Medical Letter on the CDC and FDA, September 28th, 2008

MiCardia Corporation announced that the U.S. Food and Drug Administration ("FDA") has granted 510(k) marketing clearance for its Dynaplasty(TM) Annuloplasty Band DR(TM) and Annuloplasty Ring DR. These are the first of MiCardia's innovative Dynaplasty Technology products to receive clearance.

Commenting on this approval MiCardia Chief Executive Officer, Paul Molloy said, "This is a key regulatory milestone for MiCardia which involved extensive technical validation of the Company's first generation annuloplasty system. It prepares the way for the progression of this highly unique and innovative Dynaplasty Technology and pairs with the commencement of the Company's DYANA...

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Source: Medical Letter on the CDC and FDA (2008-09-28)

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