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Product Approval Information - Licensing Action

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Proper name: Fibrin Sealant (Human)
Tradename: Crosseal
Manufacturer: OMRIX biopharmaceuticals, Ltd., BELGIUM, License #1603
Indication for Use: Adjunct to hemostasis in patients undergoing liver surgery, when control of bleeding by conventional surgical techniques is ineffective or impractical
Approval Date: 3/21/2003
Type of submission: Biologics license application

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Approval Letter - (Text)

Label - (PDF)

SBA - (PDF)

 

Updated March 28, 2003
 
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