FDAnews Device Daily Bulletin

ORTHOVITA RECEIVES FDA APPROVAL TO MARKET ITS VITAGEL SURGICAL HEMOSTAT

June 22, 2006
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Orthovita, Inc, a developer of orthopedic biomaterials, reported today that it has obtained pre-market approval (PMA) from the U.S. Food and Drug Administration to market its VITAGEL surgical hemostat. The new approval permits Orthovita to sell VITAGEL surgical hemostat manufactured at its Malvern, Pennsylvania facility. Orthovita has already manufactured three lots of VITAGEL at its facility and will begin shipping and selling this product immediately.
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