PMA supplement
P160017 S125: MiniMed 780G System
FDA PMA supplement · Panel Track · Medtronic Minimed, Inc.
Key facts
| Original PMA | P160017 |
|---|---|
| Supplement number | S125 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | MiniMed 780G System |
| Generic name | Automated insulin dosing device system, single hormonal control |
| Applicant | Medtronic Minimed, Inc. |
| Product code | OZP |
| Received date | Apr 30, 2025 |
| Decision date | Dec 11, 2025 |
| Docket number | 25M-7061 |
| Notice date | Dec 16, 2025 |
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: