Regulatory Affairs Syndicator

DakoCytomation’s c-Kit (9.7) pharmDx is used to aid identification of patients with gastrointestinal stromal tumors (GIST) and selection of patients eligible for treatment with the cancer drug Gleevec® (imatinib mesylate). It is used with an automated… (Approved: 6/27/2005)

DakoCytomation?s c-Kit (9.7) pharmDx is used to aid identification of patients with gastrointestinal stromal tumors (GIST) and selection of patients eligible for treatment with the cancer drug Gleevec® (imatinib mesylate). It is used with an automated… (Approved: 6/27/2005)

DakoCytomation?s c-Kit (9.7) pharmDx is used to aid identification of patients with gastrointestinal stromal tumors (GIST) and selection of patients eligible for treatment with the cancer drug Gleevec® (imatinib mesylate). It is used with an automated… (Approved: 6/27/2005)

The Total Temporomandibular Joint Replacement System is a prosthetic jaw joint. The device is a ball and socket joint with one side mounted to the jaw and the other side mounted to the head in front of the ear. A surgeon implants the joint after… (Approved: 9/21/2005)

The Total Temporomandibular Joint Replacement System is a prosthetic jaw joint. The device is a ball and socket joint with one side mounted to the jaw and the other side mounted to the head in front of the ear. A surgeon implants the joint after… (Approved: 9/21/2005)

The Biocor™ is a heart valve that consists of a small round device with three cusps (pieces of pig tissue that act like one-way doors), mounted in a covered plastic stent that helps keep the round shape. The Biocor™ helps to keep blood flowing in the… (Approved: 8/5/2005)

The Biocor? is a heart valve that consists of a small round device with three cusps (pieces of pig tissue that act like one-way doors), mounted in a covered plastic stent that helps keep the round shape. The Biocor? helps to keep blood flowing in the… (Approved: 8/5/2005)

The Orbasone Pain Relief System is a non-invasive, alternative to surgery that uses strong sound waves (extracorporeal shock wave energy) to relieve heel pain (proximal plantar faciitis). (Approved: 8/10/2005)

The Orthospec™ Extracorporeal Shock Wave Therapy device is a non-invasive, alternative to surgery that uses strong sound waves (extracorporeal shock wave energy) to relieve heel pain (proximal plantar fasciitis). Proximal plantar faciitis is an… (Approved: 4/1/2005)

The Orthospec? Extracorporeal Shock Wave Therapy device is a non-invasive, alternative to surgery that uses strong sound waves (extracorporeal shock wave energy) to relieve heel pain (proximal plantar fasciitis). Proximal plantar faciitis is an… (Approved: 4/1/2005)

The Onyx® LES is an artificial material used to block blood flow in the treatment of abnormally formed (malformed) blood vessels in the brain. This material is used to block the flow of blood before surgical treatment of the malformed vessels. (Approved: 7/21/2005)

Wako LBA AFP-L3 is a lab test that helps determine the risk of developing liver cancer in patients with chronic liver disease (CLD). This lab test measures how much the L3 form of AFP (alpha fetoprotein) a patient has in their blood sample. The test… (Approved: 5/19/2005)

This device has two systems: the stent and delivery catheter system (Xact® Carotid Stent System) used with an embolic protection system (Emboshield? Embolic Protection System). The stent is a metal mesh tube on a delivery catheter, and the embolic… (Approved: 9/6/2005)

The GORE VIABAHN® Endoprosthesis is used in patients who have a blockage within their femoral artery, which is caused by atherosclerotic disease. (Approved: 6/14/2005)

The Wingspan™ Stent System with Gateway™ PTA Balloon Catheter is used to open blocked arteries in the brain, allowing blood to flow to the brain. It consists of a Stent, a Delivery System, and a Balloon Catheter. The Balloon Catheter is used to open… (Approved: 8/3/2005)