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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameIMMUNOSORBA PROTEIN A COLUMN AND IMMUNOSORBA PROTEIN A SEPHAROSE COLUMN
Classification Namecolumns, immunoadsorption in extracorporeal systems
Generic Namecolumns, immunoadsorption in extracorporeal systems
Applicant
FRESENIUS MEDICAL CARE
95 hayden ave.
lexington, MA 02420
HDE NumberH970004
Date Received10/23/1997
Decision Date04/06/1998
Product Code
LQQ[ Registered Establishments with LQQ ]
Docket Number 98M-0435
Advisory Committee Gastroenterology
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
This device is indicated for use in the treatment of patient with hemophilia a and b who have factor viii or factor ix inhibitor titers above 10 bethesda unit/ml (bu/ml. The purpose of the system is to lower the inhibitor levels so that routine clotting factor replacement therapy can be considered. It may be used in an acute setting (to control bleeding during an acute hemorrhage or for emergency surgery) or as a preventative measure to prepare patients for elective surgery.
Approval OrderApproval Order
Supplements: S001 S002 S003 S004 S005 S007 S008 S009 S010 
S011 
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