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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 NamePLASMAFLO OP-05W (A)
Classification Nameseparator for therapeutic purposes, membrane automated blood cell/plasma
Generic Nameplasma separator
ApplicantASAHI KASEI MEDICAL CO., LTD.
PMA NumberP820033
Supplement NumberS005
Date Received08/18/2009
Decision Date03/16/2010
Product Code
MDP[ Registered Establishments with MDP ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the plasmaflo op-05w(a). The device, is intended as a replacement for the plasmaflo ap-05h and the plasmaflo ap-05h(l). The device will be marketed under the trade name plasmaflo op-05w(a) and is indicated for use in therapeutic procedures requiring separation of plasma from whole blood.
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