Federal Register Notice: FDA is seeking comments on the recommendation of the Circulatory System Devices Panel to reclassify Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters, other than cutting/scoring PTCA catheters, from Class 3 (premarket approval) to Class 2 (special controls). The panel made this recommendation after reviewing the reclassification petition submitted by Cook Group Inc. and other publicly available information. The agency is also making available a draft guidance document, Class 2 Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters that FDA intends will serve as the special control for this device type, if it is reclassified. To download this guidance, click here. To view this notice, click here.