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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.
 
Trade NamePROSORBA COLUMN
Classification Nameseparator, automated, blood cell and plasma, therapeutic
Generic Nametherapeutic plasma exchange
ApplicantFRESENIUS HEMOCARE, INC.
PMA NumberP850020
Supplement NumberS013
Date Received04/30/2001
Decision Date10/26/2001
Product Code
LKN[ Registered Establishments with LKN ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revised labeling that relates new post-market safety information regarding episodes of vasculitis in rheumatoid arthritis patients treated with the prosorba(r) column.
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