PMA
P120010: MINIMED 530G SYSTEM
FDA PMA · Automated insulin dosing, threshold suspend · Medtronic, Inc.
Key facts
| PMA number | P120010 |
|---|---|
| Trade name | MINIMED 530G SYSTEM |
| Generic name | Automated insulin dosing , threshold suspend |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic |
| Product code | OZO |
| Approval date | Sep 26, 2013 |
| Docket number | 13M-1206 |
| Notice date | Sep 30, 2013 |
| Establishment registration | 2032227 |
| FEI number | 3003166194 |
At a glance
- 100–999 Supplements
- Jul 21, 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- No Withdrawn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: