Approval of the revised protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p170027.
| Device | TherOx DownStream System |
| Generic Name | System, Oxygen, Aqueous |
| Applicant | TherOx, Inc. |
| Date Received | 2021-05-24 |
| Decision Date | 2021-12-09 |
| PMA | P170027 |
| Supplement | S006 |
| Product Code | MWG |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| 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