PMA supplement
P150001 S009: MINIMED 630G SYSTEM WITH SMARTGUARD
FDA PMA supplement · Real-Time Process · Medtronic Minimed
Key facts
| Original PMA | P150001 |
|---|---|
| Supplement number | S009 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | MINIMED 630G SYSTEM WITH SMARTGUARD |
| Generic name | Automated insulin dosing , threshold suspend |
| Applicant | Medtronic Minimed |
| Product code | OZO |
| Received date | Dec 23, 2016 |
| Decision date | Mar 27, 2017 |
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: