This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | PRISMAFLEX TPE2000 SET |
| Generic Name | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma |
| Applicant | BAXTER INTERNATIONAL, INC.1 Baxter Pkwy.deerfield, IL 60015-4633 PMA NumberP830063 Supplement NumberS022 Date Received03/02/2022 Decision Date03/31/2022 Product Code MDP Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-02 |
| Decision Date | 2022-03-31 |
| PMA | P830063 |
| Supplement | S022 |
| Product Code | MDP |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BAXTER INTERNATIONAL, INC. 1 Baxter Pkwy. deerfield, IL 60015-4633 PMA NumberP830063 Supplement NumberS022 Date Received03/02/2022 Decision Date03/31/2022 Product Code MDP Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement The Sponsor Has Proposed Removal Of Visual Inspection Of Two Components At Their Tunisia Plant. The Risk Assessment And The Quality Report Support This Request. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 07332414111038 | P830063 | 006 |