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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePlasmaflo OP-05W(A)
Generic NameSeparator for therapeutic purposes, membrane automated blood cell/plasma
ApplicantAsahi Kasei Medical Co., Ltd.
1-105 Kanda Jinbocho
Chiyoda-Ku
Tokyo 101-8101
PMA NumberP820033
Supplement NumberS014
Date Received02/01/2021
Decision Date03/03/2021
Product Code MDP 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change in the sterilization test method performed at the 3-month sterilization dose audit for the Plasmaflo OP-05W(A).
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