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.
Approval for modification to the indications for use statement to include a new group d - "functional hypercholesterolemic heterozygotes with ldl-c >= 100 mg/dl and lipoprotein(a) [lp(a)] >= 60 mg/dl, and either documented coronary artery disease or documented peripheral artery disease. "
| Device | LIPOSORBER LA-15 System |
| Generic Name | Lipoprotein, Low Density, Removal |
| Applicant | KANEKA PHARMA AMERICA CORP. |
| Date Received | 2019-08-13 |
| Decision Date | 2020-04-21 |
| PMA | P910018 |
| Supplement | S027 |
| Product Code | MMY |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |