Plasmaflo OP-05W(A)

FDA Premarket Approval P820033 S016

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.

Pre-market Approval Supplement Details

DevicePlasmaflo OP-05W(A)
Generic NameSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma
ApplicantAsahi Kasei Medical Co., Ltd.1-105 Kanda Jinbochochiyoda-kutokyo 101-8-8101 PMA NumberP820033 Supplement NumberS016 Date Received12/09/2022 Decision Date01/05/2023 Product Code MDP  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-12-09
Decision Date2023-01-05
PMAP820033
SupplementS016
Product CodeMDP 
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAsahi Kasei Medical Co., Ltd.
1-105 Kanda Jinbocho
chiyoda-ku
tokyo 101-8-8101 PMA NumberP820033 Supplement NumberS016 Date Received12/09/2022 Decision Date01/05/2023 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  
Approval For Change In Quality Control Testing For The Plasmaflo OP-05W (A), Regarding A Change Of Gas Chromatograph (GC) Equipment For Measurement Of Residual Propanol.

Supplemental Filings

Supplement NumberDateSupplement Type
P820033Original Filing
S016 2022-12-09 30-day Notice
S015 2022-01-11 30-day Notice
S014 2021-02-01 30-day Notice
S013 2020-09-24 30-day Notice
S012 2018-01-19 30-day Notice
S011 2017-12-20 30-day Notice
S010 2016-02-19 30-day Notice
S009 2015-11-06 30-day Notice
S008 2011-10-12 30-day Notice
S007 2010-12-15 30-day Notice
S006 2010-07-07 30-day Notice
S005 2009-08-18 Normal 180 Day Track
S004
S003
S002
S001 1984-04-20

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