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FDA Law Weekly

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Atrial Flutter



CryoCor Provides PMA Update



March 15th, 2007

CryoCor, Inc. (NASDAQ:CRYO), a medical device company focused on the treatment of cardiac arrhythmias, announced that, based upon additional information from CryoCor, the U.S. Food and Drug Administration, or FDA, may no longer need to convene an Advisory Panel meeting to render a decision on CryoCor's PMA for the treatment of atrial flutter. The additional information CryoCor is providing indicates a higher chronic effectiveness than in the amended PMA filing. The FDA has cancelled CryoCor's previously announced panel meeting while they take time to review this new information. CryoCor now expects a final decision on its PMA for the treatment of atrial flutter by August 2007, instead of...


Source: FDA Law Weekly (2007-03-15)

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