I have had the opportunity over the last 10 years to work with Drug-Eluting Coronary stents. These stents are delivered by a catheter, used to prop open the coronary artery and are coated with a drug that is absorbed into the surrounding tissue. The primary mode of action (PMOA) is to open the coronary artery. The secondary mode of action (drug) is to prevent inflammation and restenosis. The review is assigned to CDRH due to the PMOA being a device. These devices are generally classified as a Class III device and require a PMA.