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 1) replacing the sterilization date with the actual expiration date, expressed as month and year, for the liposorber(r) la-15 system components: liposorber(r) la-15 column, sulflux(r) fs-05 plasma separator, and the tubing sytem for plasmapheresis lt-ma2; 2) replacing the slip-type male tubing connectors with luer-lock type connectors on the separator end-caps of te sulflux fs-05 plasma separator; 3) making the following changes to the tubing system for the plasmapheresis lt-ma2: a) providing sterile transducer protective filters (found substantially equivalent under 510(k) k983076) in packages of ten; b) reducing the number of connection tubes from ten to eight, adding pinch clips and reducing the sharpness of the plastic spike on each end of the connection tube; c) replacing the stainless steel needles, used to connect each infusion line to a bag or bottle of saline or regeneration fluid, with plastic spikes; d) adding a luer-lock "male" and "female" connector to the end of the waste lines; e) increasing the length of the tubing section between the blood pump and chanber level 1 from 80 mm to 90 mm and the length of the tubing section between the waste drip chamber and a "t" dconnector on the waste line from 35 m to 50 mm; and f) adding an infusion line.
| Device | LIPOSORBER LA-15 SYSTEM |
| Classification Name | Lipoprotein, Low Density, Removal |
| Generic Name | Lipoprotein, Low Density, Removal |
| Applicant | KANEKA PHARMA AMERICA CORP. |
| Date Received | 2000-06-20 |
| Decision Date | 2000-12-06 |
| PMA | P910018 |
| Supplement | S005 |
| Product Code | MMY |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |