PMA
P230019: MediBeacon® Transdermal GFR Measurement System (TGFR)
FDA PMA · Transdermal test for Assessment of Glomerular Filtration Rate · Medibeacon, Inc.
Key facts
| PMA number | P230019 |
|---|---|
| Trade name | MediBeacon® Transdermal GFR Measurement System (TGFR) |
| Generic name | Transdermal test for Assessment of Glomerular Filtration Rate |
| Applicant | Medibeacon, Inc. |
| Owner/operator | MediBeacon Inc. |
| Product code | SDK |
| Approval date | Jan 17, 2025 |
| Docket number | 25M-0330 |
| Establishment registration | 3027576156 |
| FEI number | 3027576156 |
At a glance
- 1–9 Supplements
- Oct 2, 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- No Withdrawn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: