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.
Change in the bioburden recovery procedure for the plasmaflo op-05w(a).
| Device | Plasmaflo OP-05W(A) |
| 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 | 2018-01-19 |
| Decision Date | 2018-02-15 |
| PMA | P820033 |
| Supplement | S012 |
| 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 |