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Panel to Vote on NaviStar Catheter

10/15/2008

Federal Register Notice: FDA’s Circulatory System Devices Panel will meet 11/20, from 8 a.m. to 5:30 p.m. at the Gaithersburg Holiday Inn, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD. Contact James Swink, (240) 276-4050. The committee will discuss and vote on a PMA from Biosense Webster (a J&J company) for the NaviStar ThermoCool irrigated RF ablation catheter. The device, an open-lumen, irrigated tip, steerable radiofrequency cardiac ablation catheter, is inserted through the venous circulation to the heart, across the intra-atrial septum to the left atrium to ablate cardiac tissue to create lines of block in the atria to eliminate conduction patterns that theoretically generate or allow propagation of paroxysmal atrial fibrillation. To view this notice, click here.

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