PMA
P170027: TherOx Downstream System
FDA PMA · System, oxygen, aqueous · Zoll Circulation, Inc.
Key facts
| PMA number | P170027 |
|---|---|
| Trade name | TherOx Downstream System |
| Generic name | System, oxygen, aqueous |
| Applicant | Zoll Circulation, Inc. |
| Product code | MWG |
| Approval date | Apr 2, 2019 |
| Docket number | 19M-1582 |
| Notice date | Apr 4, 2019 |
| FEI number | 3003793491 |
At a glance
- 10–99 Supplements
- Apr 10, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: