www.fdanews.com/articles/82197-cryocor-says-fda-requests-more-data-on-heart-device
CRYOCOR SAYS FDA REQUESTS MORE DATA ON HEART DEVICE
November 4, 2005
CryoCor Inc. on Thursday said it has provided more data to U.S. regulators to support its premarket approval application for its heart system to treat atrial flutter.
The company said the Food and Drug Administration in late October asked primarily about added statistical analysis of patient data and clinical interpretations and data related to specific patients.