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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 for therapeutic purposes, membrane automated blood cell/plasma
Generic Nameseparator for therapeutic purposes, membrane automated blood cell/plasma
Applicant
FRESENIUS HEMOCARE, INC.
920 winter street
waltham, MA 02451
PMA NumberP850020
Supplement NumberS024
Date Received09/18/2006
Decision Date10/19/2006
Product Code
MDP[ Registered Establishments with MDP ]
Advisory Committee Gastroenterology/Urology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR LABELING CHANGES TO ADD 1) CAUTION AND PRECAUTION STATEMENTS RELATING TO THE RISK OF THROMBOSIS, 2) A CLARIFICATION REGARDING TREATMENT VOLUMES FOR IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP) PATIENTS, 3) A CLARIFICATION THAT ITP, AS WELL AS RHEUMATOID ARTHRITIS, PATIENTS MAY NOT FEEL THE EFFECTS OF PROSORBA TREATMENTS IMMEDIATELY AFTER INITIATION OF THERAPY, AND 4) A CLARIFICATION THAT TREATMENTS SHOULD BEGIN WITHIN ONE HOUR OF PRIMING.
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