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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 TREATMENT COLUMN FOR RA AND ITP
Classification Nameseparator, automated, blood cell and plasma, therapeutic
Generic Nametherapeutic plasma exchange
ApplicantFRESENIUS HEMOCARE, INC.
PMA NumberP850020
Supplement NumberS012
Date Received06/21/1999
Decision Date12/17/1999
Product Code
LKN[ Registered Establishments with LKN ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason pas protocal supplement ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of post-approval study protocols.
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