Product Approval Information
Proper Name: Fibrin Sealant
Tradename: TISSEEL
Manufacturer: Baxter Healthcare Corp, License #0140
Package Insert (PDF - 1.1 MB) - May, 1998
Date: May 1, 1998
Indication: 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
May 1, 1998 Approval Letter
SBA (PDF - 1.4 MB)
FDA Talk Paper