CryoCor to file amended PMA (premarket approval) for heart flutter cryoablation
This article was originally published in Clinica
Executive Summary
Following a setback this year when the FDA rejected its premarket approval (PMA) application to sell what could have become the first US-approved cryoablation system for treating atrial flutter, CryoCor intends to file an amended version of the PMA in the third quarter of 2006.