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.
| Device | Plasmaflo OP-05W(A) |
| Generic Name | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma |
| Applicant | Asahi Kasei Medical Co., Ltd.1-105 Kanda Jinbochochiyoda-kutokyo 101-8-8101 PMA NumberP820033 Supplement NumberS016 Date Received12/09/2022 Decision Date01/05/2023 Product Code MDP Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-12-09 |
| Decision Date | 2023-01-05 |
| PMA | P820033 |
| Supplement | S016 |
| 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 PMA NumberP820033 Supplement NumberS016 Date Received12/09/2022 Decision Date01/05/2023 Product Code MDP Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Change In Quality Control Testing For The Plasmaflo OP-05W (A), Regarding A Change Of Gas Chromatograph (GC) Equipment For Measurement Of Residual Propanol. |
| 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 |