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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 COLUMN
Classification Nameseparator, automated, blood cell and plasma, therapeutic
Generic Nametherapeutic plasma exchange
ApplicantFRESENIUS HEMOCARE, INC.
PMA NumberP850020
Supplement NumberS018
Date Received04/30/2003
Decision Date05/30/2003
Product Code
LKN[ Registered Establishments with LKN ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to the sterilization load configuration and length of sterilization cycle.
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