Approval for a labeling change to address complaints related to luer connector cracks.
| Device | GAMBRO PRISMAFLEX TPE 2000 SET |
| 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 | 2015-10-13 |
| Decision Date | 2015-11-12 |
| PMA | P830063 |
| Supplement | S008 |
| Product Code | MDP |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Special (immediate Track) |
| 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