www.fdanews.com/articles/61103-atricure-receives-fda-510-k-clearance-for-multifunctional-isolator-transpolar-pen-system-and-releases-new-isolator-transpolar-open-clamp
ATRICURE RECEIVES FDA 510(K) CLEARANCE FOR MULTIFUNCTIONAL ISOLATOR TRANSPOLAR PEN SYSTEM AND RELEASES NEW ISOLATOR TRANSPOLAR OPEN CLAMP
July 21, 2006
AtriCure, Inc., a medical device company focused on developing, manufacturing and selling innovative surgical devices, announced that it has received Food and Drug Administration (FDA) 510(k) clearance for its Isolator Transpolar Pen System (Pen) for pacing, sensing, stimulating, and recording during the evaluation
of cardiac arrhythmias in addition to its currently FDA- cleared use for the ablation of cardiac tissues. The AtriCure Pen is the only bipolar radiofrequency (RF) device
that is cleared for this broad range of indications.
Atricure