Premarket Approval Information - Devices
Applicant: ThermoGenesis Corp
Product: CryoSeal FS System
PMA number: BP060001/0
Indication for Use: For use in the automated preparation of fibrin sealant from a single unit of autologous human plasma only in a closed, sterile fluid path. The autologous fibrin sealant prepared by this device is indicated for use as an adjunct to hemostasis on the incised liver surface in patients undergoing liver resection when control of bleeding by standard surgical techniques is ineffective or impractical.
Approval Date: 7/26/2007