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Proper Name: Fibrin Sealant
Manufacturer: Baxter Healthcare Corp, License #0140
- For use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.
- An adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.
September 3, 2013 Approval Letter - Tisseel
To include revisions to the indication and usage section of the package insert and update and clarify the language in the Warnings and Precautions section on infection risk from human plasma.
January 25, 2012 Approval Letter -TISSEEL
To support the indication extension for general adjunct to hemostasis.
Clinical Review - TISSEEL(PDF - 415KB) January 29, 2010 Approval Letter - Tisseel May 1, 1998 Approval Letter - TISSEEL Summary Basis for Approval - TISSEEL(PDF - 1.5MB)
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[ARCHIVED]
July 9, 2010