Recently Approved Devices

Recently Approved Devices

The FDA has recently approved the following devices to be marketed.

Edwards Pericardial Mitral Bioprosthesis, Model 11000M - P150048/S012 This device is intended for use as an artificial heart valve. The valve is made of cow tissue and a cobalt-chromium metal frame. The device is surgically implanted through an open heart procedure. The original PMA (P150048) was approved on June 29, 2017 and is indicated for the replacement of native or prosthetic aortic heart valves. The current supplement was submitted to allow the device to be used to replace the mitral valve in addition to the aortic valve.

PK Papyrus Covered Coronary Stent System - H170004 The PK Papyrus Covered Coronary Stent System is a balloon-expandable covered stent that is advanced into a coronary artery using a balloon catheter delivery system. The stent is made from cobalt-chromium metal alloy and covered with a polyurethane membrane. The device is intended to treat coronary artery perforations, which are tears in heart blood vessels.

Eluvia Drug-Eluting Vascular Stent System - P180011 The Eluvia Drug-Eluting Vascular Stent System (Eluvia Stent) is a self-expanding, small metal (nitinol), mesh tube (stent) intended to be implanted in an artery in the thigh (femoropopliteal artery). The Eluvia stent is coated with the drug Paclitaxel,  which help prevent the artery from re-narrowing (restenosis).

Visian® Toric ICL (Implantable Collamer® Lens) – P030016/S001 The Visian® Toric ICL is an artificial lens that is permanently implanted inside the eye behind the iris and in front of the natural lens. The lens is intended to correct nearsightedness (myopia). This approval expands the use to correct blurred vision due to an irregularly shaped cornea (astigmatism). The device does not replace the natural lens.

HeartMate 3 Left Ventricular Assist System (LVAS) - P160054/S008 The HeartMate 3 LVAS is a heart pump system that helps the heart's left ventricle (the main pumping chamber of the heart) deliver blood to all parts of the body. The device is used for heart failure patients whose hearts are unable to pump blood effectively. The HeartMate 3 LVAS is made up of a blood pump that is implanted inside the patient's body and a pump controller with batteries that remains outside the patient's body.

VisuMax Femtosecond Laser - P150040/S003 This is an ophthalmic surgical laser designed to create small cuts (incisions) in the transparent layer on the front of the eye (the cornea). It is used in the VisuMax small-incision lenticule extraction or SMILE procedure, which is a surgical treatment for nearsightedness (myopia) with or without astigmatism. Supplement 3 is for the approval of the surgical treatment with astigmatism.

BioMimics 3D Vascular Stent System - P180003 The BioMimics 3D Vascular Stent System has two components; (1) a small, spiral tube (stent) made of a nickel and titanium alloy (nitinol) and (2) an over-the-wire stent delivery system. The BioMimics 3D Vascular Stent System is intended for the treatment of narrowing or reduced blood flow in the femoropopliteal artery.