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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 NameGAMBRO PLASMAFILTER, PF2000N
Classification Nameseparator, automated, blood cell and plasma, therapeutic
Generic Nameplasmafilter
ApplicantGAMBRO RENAL PRODUCTS
PMA NumberP830063
Supplement NumberS003
Date Received10/31/2000
Decision Date11/20/2000
Product Code
LKN[ Registered Establishments with LKN ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to 1) expand the instructions for use (ifus) to permit the blood flow direction during use to be opposite to the direction of flow of the rinsing and priming solutions, and to 2) remove the blood flow direction arrow from the device label.
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