Cardima®, Inc. has received pre-market approval (PMA) application for the REVELATION® Tx will be reviewed during a meeting of the U.S. FDA Circulatory System Devices Panel.

The company further reported that its manufacturing facility was recently inspected as part of the ongoing FDA marketing approval process and the Company has subsequently received a letter certifying compliance with FDA manufacturing standards.

“We continue active communications and interaction with the FDA in our efforts to complete the PMA process. Assignment of a panel date represents a major milestone in our quest to market the REVELATION Tx system in the U.S.,” said Gabriel Vegh, Cardima's chief executive officer. “We believe that Cardima currently is the only company that has completed a multi-center trial and submitted a PMA for a device to treat atrial fibrillation.”

“We reached this milestone as a result of five years of groundbreaking work in atrial fibrillation,” added Mr. Vegh. “We believe our clinical work, including promising efficacy and safety data, supports our PMA submission. We have worked hand-in-hand with the FDA throughout the submission and approval process.”