Standard percutaneous transluminal coronary angioplasty (PTCA) catheters for certain indications will now be classified as device class II (special controls) rather than class III (premarket approval) after an FDA’s decision last week published in the Federal Register. With the final rule, effective Oct. 8, these PTCA devices will have the ability to be launched on the market through the 510(k) clearance process rather than use of premarket approval applications (PMAs).
