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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 PMA to get an up-to-date view of this device.
 
DevicePROSORBA COLUMN
Classification Nameseparator, automated, blood cell and plasma, therapeutic
Generic Nameseparator, automated, blood cell and plasma, therapeutic
Applicant
FRESENIUS HEMOCARE, INC.
920 winter street
waltham, MA 02451
PMA NumberP850020
Supplement NumberS015
Date Received04/15/2002
Decision Date05/15/2002
Product Code
LKN[ Registered Establishments with LKN ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Reduction in the time of the reaction step in the manufacturing process and a decrease in the amount of carbodiimide used in the process.
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