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Zdrowie i gospodarka · 08/09/2010

FDA Reclassifies Certain PTCA Catheters from Class III to Class II

The FDA is reclassifying standard percutaneous transluminal coronary angioplasty (PTCA) catheters from class III to class II, while cutting/scoring PTCA catheters remain in class III and require premarket approval applications.

Source: Federal Register — Health and Human ServicesOpen original release →