Regulatory Affairs Syndicator

These reagents are used with the ADVIA Centaur® instrument to identify certain virus proteins associated with hepatitis B virus (HBV). (Approved: 5/31/2005)

The Duraloc® Option Ceramic Hip System is a ceramic on ceramic artificial hip replacement system, surgically implanted to completely replace a hip joint. (Approved: 5/3/2005)

The Her2 FISH pharmDx™ Kit is a kit used to identify breast cancer patients eligible for treatment with the cancer drug Herceptin® (Trastuzumab) and to determine the prognosis of a stage II, node-positive breast cancer patient. (Approved: 5/3/2005)

The Tag-It™ Cystic Fibrosis Kit is a laboratory test system that is used to detect and identify a group of variations in the gene called cystic fibrosis transmembrane conductance regulator (CFTR) in human blood specimens. Variations in CFTR gene have… (Approved: 5/9/2005)

The Matrix VSG™ System is used to seal a puncture site in the femoral artery and stop bleeding after a cardiac catheterization procedure. The Matrix VSG™ System uses a balloon catheter and two polymer powders that are mixed together to form… (Approved: 8/17/2005)

The Medtronic® SelectSecure™ Lead Model 3830 is a surgically implanted wire that connects the heart to an implanted pacemaker. The SelectSecure™ Lead Model 3830 allows a pacemaker to monitor and pace the heart and slowly releases a steroid… (Approved: 8/3/2005)