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Device classifications

This article was originally published in The Gray Sheet

Executive Summary

FDA issued a Class II special controls 1guidance document Feb. 15 for implantable intra-aneurysm pressure measurement systems after considering CardioMems' Aug. 9, 2005 reclassification petition for EndoSure. The diagnostic, cleared under a de novo 510(k) on Oct. 28, 2005, helps physicians monitor the progress of a stent graft during an endovascular abdominal aortic aneurysm repair procedure...
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