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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
Generic NameSeparator for therapeutic purposes, membrane automated blood cell/plasma
ApplicantAsahi Kasei Medical Co., Ltd.
1-105 KANDA JINBOCHO
CHIYODA-KU
TOKYO 101-8-8101
PMA NumberP820033
Supplement NumberS011
Date Received12/20/2017
Decision Date01/17/2018
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
Approval Order Statement  
Replacement of the annealing oven used in the manufacturing process of the hollow fibers for the Plasmaflo device.
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