Product Approval Information
Proper Name: Fibrin Sealant (Human)
Tradename: Evicel
Manufacturer: Omrix biopharmaceuticals Ltd, License #1603
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Date: January 2, 2008
Indication: Use in general surgery
January 2, 2008 Approval Letter
FDA Approves Sealant to Control Bleeding During Surgery - January 16, 2008
Clinical Efficacy Supplement Final Review Memo (PDF - 319 KB)
Statistical Review and Evaluation
Date: May 9, 2007
Indication: An adjunct to hemostasis for use in patients undergoing liver or vascular surgery when control of bleeding by standard surgical techniques is ineffective or impractical
May 9, 2007 Approval Letter
Press Release - FDA Approves Expanded Use for Surgical Sealant
Date: March 21, 2003
Indication: Adjunct to hemostasis in patients undergoing liver surgery, when control of bleeding by conventional surgical techniques is ineffective or impractical
March 21, 2003 Approval Letter
SBA (PDF - 39 KB)