PMA supplement
P160017 S138: Simplera Sync; Guardian Sensor (3) Transfer to MPROC; MiniMed 780G System with G4S
FDA PMA supplement · 30-Day Notice · Medtronic Minimed, Inc.
Key facts
| Original PMA | P160017 |
|---|---|
| Supplement number | S138 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Simplera Sync; Guardian Sensor (3) Transfer to MPROC; MiniMed 780G System with G4S |
| Generic name | Automated insulin dosing device system, single hormonal control |
| Applicant | Medtronic Minimed, Inc. |
| Product code | OZP |
| Received date | Jun 22, 2026 |
| Decision date | Jul 21, 2026 |
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: