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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(TM) 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 NumberS009
Date Received03/07/1997
Decision Date04/17/1997
Product Code
LKN[ Registered Establishments with LKN ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the consolidation of manufacturing operations at cypress bioscience, 14787 ne 95th st. , redmond, wa 98052.
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