Product Approval Information - Licensing Action
Proper name: Fibrin Sealant
Tradename: TISSEEL VH Kit
Manufacturer: Osterreichisches Institut Fur Haemoderivate Ges.m.b.H., A-1220 Vienna Austria, License #258
Indication for Use: 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
Approval Date: 5/1/98
Type of submission: Biologics license application
Approval Letter -
(PDF),
(Text)
SBA -
(PDF)
Label -
(PDF)
Talk Paper
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