Gore atrial septal occluder
This article was originally published in The Gray Sheet
Executive SummaryW.L Gore launches the Gore Helex septal occluder Oct. 3 with a modified catheter delivery system to close atrial septal defects. Same-day 510(k) clearance modifies the original delivery system with which the implanted prosthesis, most often used to treat heart defects in children, was first PMA-approved by FDA in August 2006
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