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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.

Read at press release


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