PMA supplement
P170022 S003: PyloPlus® UBT System
FDA PMA supplement · Panel Track · Arj Medical, Inc.
Key facts
| Original PMA | P170022 |
|---|---|
| Supplement number | S003 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | PyloPlus® UBT System |
| Generic name | Test, urea adult and pediatric (breath), |
| Applicant | Arj Medical, Inc. |
| Product code | OZA |
| Received date | May 23, 2023 |
| Decision date | Jan 11, 2024 |
| Docket number | 24M-0280 |
| Notice date | Jan 12, 2024 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: