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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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CryoSeal FS System

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

Letter

Package Insert (PDF - 458 KB)

Summary of Safety and Effectiveness (PDF - 123 KB)

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448
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