Medical Device Approvals

The VIDAS fPSA rt Assay is a lab tests, used along with digital rectal examination, to help diagnose prostate cancer in men age 50 years and older. (Approved: 10/8/2009)

The DuraSeal Spine Sealant System is used in spinal surgery and applied over sutures (stitches) to prevent cerebrospinal fluid (CSF) from leaking out of the incision site. (Approved: 9/4/2009)

Sculptra Aesthetic is an implant of poly-L-lactic acid (PLLA) microparticles. It is injected into the facial tissue to correct shallow to deep smile lines (nasolabial fold) contour deficiencies and other facial wrinkles. (Approved: 7/28/2009)

The TAXUS® Liberte™ Long (2.75?4.00 mm x 38 mm) Paclitaxel-Eluting Coronary Stent is an expandable, mesh-like stainless steel tube with a drug (paclitaxel) contained within a thin polymer coating on its surface. (Approved: 7/13/2009)

The TAXUS® Liberté® Atom™ (2.25 mm) Paclitaxel-Eluting Coronary Stent is an expandable, mesh-like stainless steel tube with a drug (paclitaxel) contained within a thin polymer coating on its surface. (Approved: 5/21/2009)

The BRYAN® Cervical Disc is a titanium and polyurethane device that fits between adjacent neck bones (vertebral bodies) to replace a diseased or bulging cervical disc that is causing neck or arm pain. (Approved: 5/12/2009)

The BRYAN® Cervical Disc is a titanium and polyurethane device that fits between adjacent neck bones (vertebral bodies) to replace a diseased or bulging cervical disc that is causing neck or arm pain. (Approved: 5/12/2009)

REPEL-CV Bioresorbable Adhesion Barrier is a single use, synthetic, bioresorbable polymeric film composed of poly-lactic acid (PLA) and polyethylene glycol (PEG). (Approved: 3/6/2009)

REPEL-CV Bioresorbable Adhesion Barrier is a single use, synthetic, bioresorbable polymeric film composed of poly-lactic acid (PLA) and polyethylene glycol (PEG). (Approved: 3/6/2009)

The ARCHITECT ® CORE Reagent Kit , Calibrator, and Controls constitute a laboratory test used to detect antibodies (anti HBc) associated with the hepatitis B virus (HBV) core antigen. (Approved: 4/10/2009)