PMA supplement
P160017 S048: MiniMed 670G Insulin Pump Guardian Link (3) Transmitter
FDA PMA supplement · Normal 180 Day Track · Medtronic Minimed, Inc.
Key facts
| Original PMA | P160017 |
|---|---|
| Supplement number | S048 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | MiniMed 670G Insulin Pump Guardian Link (3) Transmitter |
| Generic name | Automated insulin dosing device system, single hormonal control |
| Applicant | Medtronic Minimed, Inc. |
| Product code | OZP |
| Received date | Jul 23, 2018 |
| Decision date | Nov 20, 2018 |
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: