Medical Device Approvals

What is it? A totally implanted brain stimulator intended to suppress symptoms associated with Obsessive Compulsive Disorder (OCD) that are not adequately controlled with medications and/or other therapies. (Approved: 2/19/2009)

The TECNIS® Multifocal Foldable Intraocular Lens is a plastic lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. (Approved: 1/16/2009)

BIOFINITY® is an extended wear soft contact lens that may be worn continuously for up to 6 nights and 7 days. The lens material is approximately 48% water and 52% comfilcon A (a silicone-containing hydrogel). (Approved: 11/19/2008)

The Express® SD Renal Monorail® Premounted Stent System is used to re-open stenotic (narrowed) regions of the renal arteries which supply blood to the kidneys, and it consists of two components, the stent and the delivery system. (Approved: 12/11/2008)

The E-LUMINEXX Vascular Stent is a thin, flexible metal mesh tube that can be implanted in the large arteries that supply blood to the pelvis and legs (iliac arteries). (Approved: 12/4/2008)

This laboratory test measures the amount of hepatitis C viral RNA in a patient?s blood. Viral RNA (ribonucleic acid) is genetic material from the hepatitis C virus. (Approved: 10/30/2008)

The products listed on this page include some of the newest medical technology available. Each product listing contains information about what medical uses the device is approved for, when it can be used, and when it should not be used. This information, along with information from your doctor and other sources, can help make you an informed participant in your health care.