Product Information

• Package Insert - EVICEL Fibrin Sealant (Human) (PDF - 138KB)

Supporting Documents

• August 26, 2011 Approval Letter - EVICEL
• Statistical Review and Evaluation - Evicel
• January 2, 2008 Approval Letter - Evicel
  Use in general surgery
• Clinical Efficacy Supplement Final Review Memo - Evicel (PDF - 319KB)
• May 9, 2007 - Evicel
  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
• March 21, 2003 - Evicel
  Adjunct to hemostasis in patients undergoing liver surgery, when control of bleeding by conventional surgical techniques is ineffective or impractical
• Summary Basis for Approval - Evicel (PDF - 38KB)

Related Information

• FDA Online Label Repository
  Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.
• FDA Safety Notification: Risk of Air or Gas Embolism When Using Air- or Gas- Pressurized Spray Devices
  July 9, 2010
• FDA Safety Notification: Risk of Life-Threatening Air or Gas Embolism with the Use of Spray Devices Employing Pressure Regulator to Administer Fibrin Sealants - Evicel
  September 22, 2009
• FDA Approves Sealant to Control Bleeding During Surgery
  Press Release: January 16, 2008
• FDA Approves Expanded Use for Surgical Sealant
  Press Release - May 15, 2007

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