This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR |
| Classification Name | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma |
| Generic Name | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma |
| Applicant | Asahi Kasei Medical Co., Ltd. |
| Date Received | 1982-05-26 |
| Decision Date | 1983-07-05 |
| Notice Date | 1983-08-12 |
| PMA | P820033 |
| Supplement | S |
| Product Code | MDP |
| Docket Number | 83M-0236 |
| Advisory Committee | Gastroenterology/Urology |
| 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 |