Device tracking
This article was originally published in The Gray Sheet
Executive Summary
Abdominal aortic aneurysm stent grafts are added to the list of devices that require tracking in revised final guidance that supersedes guidance issued Feb. 19 (1"The Gray Sheet" Feb. 15, p. 11). Tracking orders for the stent grafts were issued Sept. 28. Other revisions clarify that tracking is only required for infusion pumps that are electromechanical and heart valves that are mechanical
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