Published on June 28, 2007 at 5:47 AM
CryoCor, Inc. has announced that the Advisory Panel of the United States Food and Drug Administration, or FDA, recommended that CryoCor's application for pre-market approval, or PMA, for the treatment of atrial flutter be approved by the FDA.
The meeting of the Advisory Panel was held on June 27, 2007 and a decision from the FDA on CryoCor's PMA is expected in August 2007. The FDA usually follows the recommendation of its Advisory Panels; however, it is not required to do so.
Dr. Helen Barold, M.D. said, "We are pleased with the decision by the Advisory Panel to recommend our PMA for approval and look forward to the FDA's decision in August. We also look forward to working with the FDA to finalize the proper labeling for our medical device and begin our commercialization efforts in the United States."
http://www.cryocor.com/