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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 NumberS008
Date Received10/12/2011
Decision Date11/02/2011
Product Code
MDP[ Registered Establishments with MDP ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Moving the plasmaflo manufacturing equipment to a new facility located within the current manufacturing site.
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