Plasmaflo OP-05W (A)

FDA Premarket Approval P820033 S015

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

Use of new equipment for the evoh coating process, and the hollow fiber (hf) drying process to increase the hollow fiber drying capacity

DevicePlasmaflo OP-05W (A)
Generic NameSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma
ApplicantAsahi Kasei Medical Co., Ltd.
Date Received2022-01-11
Decision Date2022-02-08
PMAP820033
SupplementS015
Product CodeMDP 
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Asahi Kasei Medical Co., Ltd. 1-105 Kanda Jinbocho chiyoda-ku tokyo 101-8-8101

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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