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 | TherOx Downstream System |
| Generic Name | System, Oxygen, Aqueous |
| Applicant | TherOx, Inc.17500 Cartwright Rdsuite 100irvine, CA 92614-5846 PMA NumberP170027 Supplement NumberS009 Date Received12/17/2021 Decision Date03/10/2022 Product Code MWG Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2021-12-17 |
| Decision Date | 2022-03-10 |
| PMA | P170027 |
| Supplement | S009 |
| 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 PMA NumberP170027 Supplement NumberS009 Date Received12/17/2021 Decision Date03/10/2022 Product Code MWG Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For A New Material Plasticizer For The Tubing Associated With The TherOx SSO2 DownStream Cartridge – Part Of The TherOx Downstream System. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 20862478000463 | P170027 | 000 |
| 20862478000456 | P170027 | 000 |
| 20862478000449 | P170027 | 000 |
| 20862478000432 | P170027 | 000 |
| 10862478000428 | P170027 | 000 |
| 00862478000414 | P170027 | 000 |
| 00862478000407 | P170027 | 000 |