PMA supplement
P170027 S006: TherOx DownStream System
FDA PMA supplement · Normal 180 Day Track No User Fee · Zoll Circulation, Inc.
Key facts
| Original PMA | P170027 |
|---|---|
| Supplement number | S006 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | TherOx DownStream System |
| Generic name | System, oxygen, aqueous |
| Applicant | Zoll Circulation, Inc. |
| Product code | MWG |
| Received date | May 24, 2021 |
| Decision date | Dec 9, 2021 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: