PMA
P170022: PyloPlus UBT System
FDA PMA · Test, urea adult and pediatric (breath), · Arj Medical, Inc.
Key facts
| PMA number | P170022 |
|---|---|
| Trade name | PyloPlus UBT System |
| Generic name | Test, urea adult and pediatric (breath), |
| Applicant | Arj Medical, Inc. |
| Owner/operator | ARJ MEDICAL, LLC |
| Product code | OZA |
| Approval date | Feb 18, 2020 |
| Docket number | 20M-0985 |
| Notice date | Feb 26, 2020 |
| Establishment registration | 3004577174 |
| FEI number | 3004577174 |
At a glance
- 1–9 Supplements
- Feb 5, 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- No Withdrawn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: