Cardima Revelation Tx system
This article was originally published in The Gray Sheet
Executive Summary
FDA's Circulatory System Devices Panel will review minimally invasive, linear ablation microcatheter system to treat atrial fibrillation May 29. Cardima is the only firm that has completed a multi-center trial and submitted a PMA for an AF-treating device, the firm claims March 6. Separately, FDA sends a letter to Cardima certifying compliance of its manufacturing facility after a recent inspection, the firm reports...