Vaccines, Blood & Biologics
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TISSEEL
Proper Name: Fibrin Sealant
Tradename: TISSEEL
Manufacturer: Baxter Healthcare Corp, License #0140
Indication:
- For use as an Adjunct to hemostasis in surgeries involving cardiopulmonary bypass and treatment of splenic injuries due to blunt or penetrating trauma to the abdomen, when control of bleeding by conventional surgical techniques, including suture, ligature, and cautery, is ineffective or impractical; also indicated as an adjunct for the closure of colostomies
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Supporting Documents
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)
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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
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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