FDA Releases Draft Guidance for PTCA Catheters

Summary

The Food and Drug Administration (FDA) has published a draft guidance document outlining the special controls for Class II Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters, which are expected to support the reclassification of these devices from Class III to Class II, following a recommendation by the Circulatory System Devices Panel.