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CryoLife Receives Humanitarian Use Device Designation for SynerGraft(R) Processed Human Aortic Heart Valves
Cryolife, 10/07/09
CryoLife, Inc., an implantable biological medical device and cardiovascular tissue processing company, announced that it has received a Humanitarian Use Device designation from the Food and Drug Administration for its CryoValve SG aortic human heart valve. The HUD designation is the first step in obtaining a Humanitarian Device Exemption for the CryoValve SG aortic human heart valve, which is processed with the Company's proprietary SynerGraft technology. An approved HDE would allow the Company to market the CryoValve SG aortic human heart valve.
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