Cardiovascular devices; reclassification of certain percutaneous transluminal coronary angioplasty (PTCA) catheters. Final rule.
The Food and Drug Administration (FDA) is reclassifying the device type, standard percutaneous transluminal coronary angioplasty (PTCA) catheters, from class III (premarket approval) into class II (special controls). Cutting/scoring PTCA catheters remain in class III and continue to require premarket approval applications (PMAs). FDA is reclassifying these devices in accordance with the Federal Food, Drug, and Cosmetic Act (the act). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled ``Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters'' that will serve as the special control for the reclassified device type.
D015906:Angioplasty, Balloon, Coronary / Q000145:classification* / Q000295:instrumentation; D002404:Catheterization / Q000145:classification* / Q000295:instrumentation; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000145:classification*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration