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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
 
Trade NameEXCORIM IMMUNOADSORPTION SYSTEM
Classification Namecolumns, immunoadsorption in extracorporeal systems
Generic Namecolumns, immunoadsorption in extracorporeal systems
Applicant
FRESENIUS MEDICAL CARE
95 hayden ave.
lexington, MA 02420
HDE NumberH970004
Supplement NumberS004
Date Received01/21/2004
Decision Date02/20/2004
Product Code
LQQ
Advisory Committee Gastroenterology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for labeling changes to recommend the pre- and post-treatmentevaluation of mercury levels in patients undergoing immunosorba treatmentsand to contraindicate the use of the immunosorba column in pregnant patients.
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