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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 PROTEIN A IMMUNOADSORPTION COLUMN
Classification Nameseparator, automated, blood cell and plasma, therapeutic
Generic Nametherapeutic plasma exchange
ApplicantFRESENIUS MEDICAL CARE
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: sterilizer
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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