Regulatory Affairs Syndicator

A catheter is a flexible hollow plastic tube about the thickness of a piece of spaghetti that can be placed into a body cavity. An ?ablation catheter? is a catheter used to destroy (ablate) abnormal tissue. (Approved: 11/18/2005)

GEM 21S is a dental bone filling device with a biological component that is used to treat patients who have bone defects due to periodontal disease. (Approved: 11/18/2005)

GEM 21S is a dental bone filling device with a biological component that is used to treat patients who have bone defects due to periodontal disease. (Approved: 11/18/2005)

The ACRYSOF® Toric IOLs are artificial lenses implanted in the eye to restore vision after a clouded natural lens (cataract) is removed. (Approved: 9/14/2005)

The ACRYSOF® Toric IOLs are artificial lenses implanted in the eye to restore vision after a clouded natural lens (cataract) is removed. (Approved: 9/14/2005)

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)

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)