Approval for a change of material used in the housing of the device, end cap configuraiton modification and specification chagnes to the device membrane (i. E. , decrease in number of hollow fibers and increase in hollow fiber length). The device, as modified, will be marketed under the trade name gambro ab plasmafilter pf 2000n and excorim kb maxo plasmafilter and is indicated for use in therapeutic plasmafiltration in diseases where removal of plasma components are indicted, including plasmafiltration procedureswhere filtered plasma is reinfused
| Device | GAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER |
| Classification Name | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma |
| Generic Name | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma |
| Applicant | BAXTER INTERNATIONAL, INC. |
| Date Received | 1995-07-06 |
| Decision Date | 1996-08-28 |
| PMA | P830063 |
| Supplement | S001 |
| Product Code | MDP |
| 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 | BAXTER INTERNATIONAL, INC. 1 Baxter Pkwy. deerfield, IL 60015-4633 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P830063 | | Original Filing |
| S024 |
2022-10-18 |
30-day Notice |
| S023 |
2022-03-29 |
30-day Notice |
| S022 |
2022-03-02 |
30-day Notice |
| S021 | | |
| S020 |
2021-11-09 |
Real-time Process |
| S019 |
2021-05-26 |
30-day Notice |
| S018 | | |
| S017 |
2020-07-29 |
30-day Notice |
| S016 |
2020-03-05 |
Real-time Process |
| S015 |
2020-02-24 |
Special (immediate Track) |
| S014 |
2019-11-15 |
30-day Notice |
| S013 | | |
| S012 |
2019-06-27 |
Real-time Process |
| S011 | | |
| S010 |
2017-10-26 |
30-day Notice |
| S009 |
2016-12-02 |
30-day Notice |
| S008 |
2015-10-13 |
Special (immediate Track) |
| S007 |
2015-05-29 |
30-day Notice |
| S006 |
2007-10-09 |
Real-time Process |
| S005 |
2006-11-24 |
Normal 180 Day Track |
| S004 |
2001-11-13 |
Normal 180 Day Track |
| S003 |
2000-10-31 |
Real-time Process |
| S002 |
2000-01-18 |
Normal 180 Day Track |
| S001 |
1995-07-06 |
Normal 180 Day Track |
NIH GUDID Devices