Approval for an increase in membrane length and an increase inhousing length of the heparin adsorber. The device, as modified, will be marketed under the trade name heparin adsorber 400 and is indicated for use as a component of the h. E. L. P futura apheresis system, used for the removal, by ionic exchange, of excess heparin added to precipitate lipoproteins from plasma.
| Device | H.E.L.P. PLASMAT FUTURA SYSTEM |
| Classification Name | Lipoprotein, Low Density, Removal |
| Generic Name | Lipoprotein, Low Density, Removal |
| Applicant | B. Braun Avitum AG |
| Date Received | 2012-12-20 |
| Decision Date | 2013-02-22 |
| PMA | P940016 |
| Supplement | S015 |
| Product Code | MMY |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | B. Braun Avitum AG schwarzenberger Weg 73-79 melsungen D-342-3421 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P940016 | | Original Filing |
| S027 |
2018-09-28 |
135 Review Track For 30-day Notice |
| S026 |
2018-06-15 |
135 Review Track For 30-day Notice |
| S025 |
2018-06-07 |
30-day Notice |
| S024 |
2017-10-11 |
30-day Notice |
| S023 |
2017-06-08 |
30-day Notice |
| S022 |
2016-10-17 |
30-day Notice |
| S021 |
2016-06-13 |
Real-time Process |
| S020 |
2015-11-02 |
135 Review Track For 30-day Notice |
| S019 |
2015-05-21 |
30-day Notice |
| S018 |
2015-05-21 |
30-day Notice |
| S017 |
2015-05-21 |
30-day Notice |
| S016 |
2013-09-13 |
Normal 180 Day Track |
| S015 |
2012-12-20 |
Real-time Process |
| S014 |
2011-07-19 |
Normal 180 Day Track |
| S013 |
2009-09-30 |
Normal 180 Day Track |
| S012 |
2009-02-19 |
Real-time Process |
| S011 |
2009-02-19 |
Real-time Process |
| S010 | | |
| S009 |
2002-06-07 |
Normal 180 Day Track |
| S008 | | |
| S007 | | |
| S006 | | |
| S005 | | |
| S004 |
1998-12-15 |
Normal 180 Day Track |
| S003 | | |
| S002 | | |
| S001 |
1998-11-02 |
Normal 180 Day Track |
NIH GUDID Devices