Approval to 1) expand the instructions for use (ifus) to permit the blood flow direction during use to be opposite to the direction of flow of the rinsing and priming solutions, and to 2) remove the blood flow direction arrow from the device label.
| Device | GAMBRO PLASMAFILTER, PF2000N |
| 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 | 2000-10-31 |
| Decision Date | 2000-11-20 |
| PMA | P830063 |
| Supplement | S003 |
| Product Code | MDP |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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