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.
A new polymer supplier.
Device | PLASMAFLO OP-05W (A) |
Generic Name | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma |
Applicant | Asahi Kasei Medical Co., Ltd. |
Date Received | 2010-12-15 |
Decision Date | 2011-01-28 |
PMA | P820033 |
Supplement | S007 |
Product Code | MDP |
Advisory Committee | Gastroenterology/Urology |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | Asahi Kasei Medical Co., Ltd. 1-105 Kanda Jinbocho chiyoda-ku tokyo 101-8-8101 |
Supplement Number | Date | Supplement Type |
---|---|---|
P820033 | Original 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 |