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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 PROTEIN A IMMUNOADSORPTION COLUMN
Generic NameSeparator, automated, blood cell and plasma, therapeutic
ApplicantFresenius Hemocare, Inc.
920 Winter St.
Waltham, MA 02451
PMA NumberP850020
Supplement NumberS020
Date Received07/01/2005
Decision Date08/17/2005
Withdrawal Date04/14/2008
Product Code LKN 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ETHYLENE OXIDE (EO) STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, INC., WAUKEGAN, ILLINOIS.
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