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 to the bioburden recovery procedure of the sterilization process used for the sulflux® kp-05 plasma filter device, a component of the liposorber® la-15 system.
| Device | Liposorber LA-15 System |
| Classification Name | Lipoprotein, Low Density, Removal |
| Generic Name | Lipoprotein, Low Density, Removal |
| Applicant | KANEKA PHARMA AMERICA CORP. |
| Date Received | 2018-03-29 |
| Decision Date | 2018-04-12 |
| PMA | P910018 |
| Supplement | S025 |
| Product Code | MMY |
| 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 | KANEKA PHARMA AMERICA CORP. 546 Fifth Ave., 21st Floor new York, NY 10036 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910018 | Original Filing | |
| S034 | 2022-05-31 | 30-day Notice |
| S033 | 2022-03-30 | 30-day Notice |
| S032 | 2021-12-17 | Special (immediate Track) |
| S031 | 2021-06-28 | 30-day Notice |
| S030 | 2021-03-31 | 30-day Notice |
| S029 | ||
| S028 | 2020-11-27 | 30-day Notice |
| S027 | 2019-08-13 | Normal 180 Day Track |
| S026 | 2019-04-23 | 30-day Notice |
| S025 | 2018-03-29 | 30-day Notice |
| S024 | 2018-03-01 | 30-day Notice |
| S023 | 2018-02-16 | Normal 180 Day Track |
| S022 | 2017-03-31 | Normal 180 Day Track |
| S021 | 2016-07-29 | Normal 180 Day Track |
| S020 | 2016-04-20 | Normal 180 Day Track |
| S019 | 2016-04-08 | 30-day Notice |
| S018 | 2016-02-16 | 30-day Notice |
| S017 | 2015-04-10 | Normal 180 Day Track |
| S016 | 2012-05-21 | 30-day Notice |
| S015 | 2011-11-08 | Normal 180 Day Track |
| S014 | ||
| S013 | 2009-10-27 | Normal 180 Day Track No User Fee |
| S012 | 2006-09-08 | Normal 180 Day Track |
| S011 | 2006-04-20 | Normal 180 Day Track |
| S010 | ||
| S009 | 2003-01-15 | 30-day Notice |
| S008 | ||
| S007 | 2000-08-22 | Normal 180 Day Track |
| S006 | 2000-08-07 | 30-day Notice |
| S005 | 2000-06-20 | Normal 180 Day Track |
| S004 | ||
| S003 | ||
| S002 | 1998-12-15 | Normal 180 Day Track |
| S001 | 1998-11-02 | Normal 180 Day Track |