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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePROSORBA COLUMN
Generic NameSeparator for therapeutic purposes, membrane automated blood cell/plasma
ApplicantFresenius Hemocare, Inc.
920 Winter St.
Waltham, MA 02451
PMA NumberP850020
Supplement NumberS022
Date Received03/31/2006
Decision Date06/22/2006
Withdrawal Date04/14/2008
Product Code MDP 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A LABELING CHANGE TO INCLUDE INFORMATION ON THE USE OF THE HAEMONETICS MCS AND HAEMONETICS MCS+ PLASMAPHERESIS SYSTEMS IN CONJUNCTION WITH THE PROSORBA COLUMN.
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