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.
Approval for the liposorber la-15 system. The device is a low density lipoprotein (ldl) apheresis sytem
| Device | LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2). |
| Classification Name | Lipoprotein, Low Density, Removal |
| Generic Name | Lipoprotein, Low Density, Removal |
| Applicant | KANEKA PHARMA AMERICA CORP. |
| Date Received | 1991-03-26 |
| Decision Date | 1996-02-21 |
| Notice Date | 1996-07-01 |
| PMA | P910018 |
| Supplement | S |
| Product Code | MMY |
| Docket Number | 96M-0193 |
| Advisory Committee | Gastroenterology/Urology |
| 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 |