Smith & Nephew to go before FDA panel
This article was originally published in The Gray Sheet
Executive Summary
Orthopedic & Rehabilitation Devices Panel will review the firm's PMA application for its Birmingham Hip Resurfacing product Sept. 8 in Gaithersburg, Md. The cemented femoral component and uncemented acetabular component preserve the femoral head, unlike conventional hip surgery. Product is tailored to younger, more active patients, according to the firm (1"The Gray Sheet" March 15, 2004, p. 22). The panel will meet on Sept. 9 to discuss clinical trial designs for spinal devices for treating mild-to-moderate low back pain...