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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 PROTEIN A IMMUNOADSORPTION COLUMN
Classification Nameseparator, automated, blood cell and plasma, therapeutic
Generic Nameseparator, automated, blood cell and plasma, therapeutic
Applicant
FRESENIUS HEMOCARE, INC.
920 winter street
waltham, MA 02451
PMA NumberP850020
Supplement NumberS020
Date Received07/01/2005
Decision Date08/17/2005
Product Code
LKN[ Registered Establishments with 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 Product No
Approval Order Statement 
Approval for ethylene oxide (eo) sterilization site located at steris isomedix services, inc. , waukegan, illinois.
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