PMA supplement
P230019 S001: MediBeacon® Transdermal GFR Measurement System (TGFR)
FDA PMA supplement · Normal 180 Day Track · Medibeacon, Inc.
Key facts
| Original PMA | P230019 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | MediBeacon® Transdermal GFR Measurement System (TGFR) |
| Generic name | Transdermal test for Assessment of Glomerular Filtration Rate |
| Applicant | Medibeacon, Inc. |
| Product code | SDK |
| Received date | Mar 4, 2025 |
| Decision date | Dec 15, 2025 |
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: