Approval for the therox downstream system. This device is indicated for the preparation and delivery of supersaturated oxygen therapy (sso2 therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (pci) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (ami) symptoms caused by a left anterior descending artery infarct lesion.
| Device | TherOx Downstream System |
| Generic Name | System,oxygen,aqueous |
| Applicant | TherOx, Inc. |
| Date Received | 2017-09-15 |
| Decision Date | 2019-04-02 |
| PMA | P170027 |
| Supplement | S |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TherOx, Inc. 17500 Cartwright Rd suite 100 irvine, CA 92614-5846 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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