PMA
P160017: MiniMed 670G System
FDA PMA · Automated insulin dosing device system, single hormonal control · Medtronic Minimed, Inc.
Key facts
| PMA number | P160017 |
|---|---|
| Trade name | MiniMed 670G System |
| Generic name | Automated insulin dosing device system, single hormonal control |
| Applicant | Medtronic Minimed, Inc. |
| Owner/operator | Medtronic |
| Product code | OZP |
| Approval date | Sep 28, 2016 |
| Docket number | 16M-1972 |
| Notice date | Sep 28, 2016 |
| Establishment registration | 2032227 |
| FEI number | 3003166194 |
At a glance
- 100–999 Supplements
- Sep 29, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: