Federal Register Notice: FDA is making available a guidance, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. It is intended to support the reclassification of PTCA catheters, other than cutting/scoring PTCA catheters, from Class 3 (premarket approval) into Class 2 (special controls). To download this guidance, click here. To view this notice, click here.
