For the ds-2 console. The ds-2 console uses the same cartridge as the ds-1 console; however, it has updated hardware and software to accommodate a touchscreen display in addition to modified electrical components to comply with the eu rohs standard.
| Device | TherOx Downstream System |
| Generic Name | System, Oxygen, Aqueous |
| Applicant | TherOx, Inc. |
| Date Received | 2019-08-19 |
| Decision Date | 2020-03-11 |
| PMA | P170027 |
| Supplement | S002 |
| Product Code | MWG |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TherOx, Inc. 17500 Cartwright Rd suite 100 irvine, CA 92614-5846 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P170027 | | Original Filing |
| S010 |
2022-09-30 |
30-day Notice |
| S009 |
2021-12-17 |
Normal 180 Day Track |
| S008 | | |
| S007 | | |
| S006 |
2021-05-24 |
Normal 180 Day Track No User Fee |
| S005 |
2021-03-23 |
Normal 180 Day Track No User Fee |
| S004 |
2021-03-12 |
30-day Notice |
| S003 |
2021-02-25 |
30-day Notice |
| S002 |
2019-08-19 |
Normal 180 Day Track |
| S001 | | |
NIH GUDID Devices