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US FDA to reclassify PTCA catheters

This article was originally published in RAJ Devices

Executive Summary

The US Food and Drug Administration is reclassifying standard percutaneous transluminal coronary angioplasty catheters, other than cutting or scoring catheters, from Class III (premarket approval) to Class II (special controls)1,2. The FDA has issued a final rule in the Federal Register, effective 8 October, as well as a guidance document identifying the classification regulation and product code for PTCA catheters.

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