www.fdanews.com/articles/81739-medicalcv-announces-510-k-clearance-fda-approval-to-market-the-second-generation-atrilaze
MEDICALCV ANNOUNCES 510(K) CLEARANCE, FDA APPROVAL TO MARKET THE SECOND GENERATION ATRILAZE
October 18, 2005
MedicalCV, Inc. (OTC Bulletin Board: MDCV -- News), www.medcvinc.com, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to go to market with the Company's Malleable Surgical Ablation Probe for use on cardiac tissue in surgery. This second generation product provides surgeons desired flexibility in delivering laser energy in confined spaces. MedicalCV is a cardiovascular surgery company focused on developing a truly minimally invasive procedure (closed chest, beating heart) for the treatment of atrial fibrillation by utilizing a platform of laser-based technology for cardiac tissue ablation in surgery.
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