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.
Use of new equipment for the evoh coating process, and the hollow fiber (hf) drying process to increase the hollow fiber drying capacity
| Device | Plasmaflo OP-05W (A) |
| Generic Name | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma |
| Applicant | Asahi Kasei Medical Co., Ltd. |
| Date Received | 2022-01-11 |
| Decision Date | 2022-02-08 |
| PMA | P820033 |
| Supplement | S015 |
| 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 |