Approval to change the test method for total blood volume (tbv) and to remove tbv acceptance criteria for the batch release of the h. E. L. P. Ultrafilter hips 20.
| Device | Heparin-Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System |
| Classification Name | Lipoprotein, Low Density, Removal |
| Generic Name | Lipoprotein, Low Density, Removal |
| Applicant | B. Braun Avitum AG |
| Date Received | 2018-06-15 |
| Decision Date | 2019-05-22 |
| PMA | P940016 |
| Supplement | S026 |
| Product Code | MMY |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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