PMA
P150001: MINIMED 630G SYSTEM WITH SMARTGUARD(TM)
FDA PMA · Automated insulin dosing, threshold suspend · Medtronic Minimed
Key facts
| PMA number | P150001 |
|---|---|
| Trade name | MINIMED 630G SYSTEM WITH SMARTGUARD(TM) |
| Generic name | Automated insulin dosing , threshold suspend |
| Applicant | Medtronic Minimed |
| Owner/operator | Medtronic |
| Product code | OZO |
| Approval date | Aug 10, 2016 |
| Docket number | 16M-2500 |
| Notice date | Sep 6, 2016 |
| 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- No Withdrawn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: