FDA Orthopaedic and Rehabilitation Devices Panel Rejects PMA Application for Spine Anti-Adhesion Gel by 5-2 Vote
7/17/2008 8:31:34 AM
Ortho -- In its first meeting in a year, on July 15 the FDA Orthopaedic and Rehabilitation Devices Panel voted 5-2 against recommending the premarket approval application for a spinal anti-adhesion gel intended for use in patients undergoing lumbar spine surgery. Oxiplex S/P Gel, a tissue barrier product (FzioMed Inc., San Luis Obispo, Calif.), is approved for use in 49 countries, including Canada. It has been used in about 100,000 procedures worldwide, company officials said.