Federal Register Final rule: FDA is reclassifying the device type, standard percutaneous transluminal coronary angioplasty (PTCA) catheters, from Class 3 (premarket approval) into Class 2 (special controls). Cutting/scoring PTCA catheters remain in Class 3 and continue to require PMAs. FDA is reclassifying these devices in accordance with the Federal Food, Drug, and Cosmetic Act. To view this final rule, click here.
