Approval for design modifications to the plasmat secura system including the use of the plasmat futura machine with software version 2. 6. 01, the futura kit, and individually packaged components. The device, as modified, will be marketed under the trade name h. E. L. P. Plasmat futura apheresis system and is indicated for acutely removing low-density lipoprotein cholesterol (ldl-c) from the plasma of the following high-risk patient populations for whom diet has been ineffective and maximum drug therapy has either been ineffective or not tolerated:group a: functional hypocholesterol-emic homozygotes with ldl-c > 500 mg/dl; group b: functional hypocholesterol-emic homozygotes with ldl-c > 300 mg/dl; and group c: functional hypocholesterol-emic homozygotes with ldl-c > 200 mg/dl and documented coronary artery disease.
| Device | H.E.L.P. PLASMAT FUTURA APHERESIS SYSTEM |
| Classification Name | Lipoprotein, Low Density, Removal |
| Generic Name | Lipoprotein, Low Density, Removal |
| Applicant | B. Braun Avitum AG |
| Date Received | 2009-09-30 |
| Decision Date | 2010-07-22 |
| PMA | P940016 |
| Supplement | S013 |
| 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 | 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