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Company Bayer / Calcium Chloride Solutions / BP / Aa / Kit TISSEEL@ VH TISSEEL@ VH & THROMBIN Solutions / IMMUNO AG / / Country United States / / Currency USD / / Event FDA Phase / / IndustryTerm bulk intermediate plasma products / Final product / plastic device / real-time studies / eneral laboratory equipment / manufacturing steps / chloride solution / biological product / manufacturing / biocompatible carrier materials / purified intermediate plasma products / stainless steel stirring propeller / stainless steel pressure tank / / MedicalCondition hemophilia A / sterility / abscesses / infections / injuries / / MedicalTreatment bypass / cautery / surgery / / Organization Center for Devices and Radiological Health / FDA / European Pharmacopoeia Unit / Center for Biologics Evaluation and Research / / Person Fibrinolysis Inhibitor / / Position General / / Product Trasylol / sodium chloride / Calcium Chloride / glycine / this / Page9of / Thrombin / Sealer / ELA / /
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SUMMARY BASIS FOR APPROVAL Reference Numbers: [removed]and[removed]Biological Product Name: