PMA supplement
P120005 S091: G5 Mobile Continuous Glucose Monitoring System, G6 Continuous Glucose Monitoring System, G7 Continuous Glucose Monitorin
FDA PMA supplement · Normal 180 Day Track No User Fee · Dexcom, Inc.
Key facts
| Original PMA | P120005 |
|---|---|
| Supplement number | S091 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | G5 Mobile Continuous Glucose Monitoring System, G6 Continuous Glucose Monitoring System, G7 Continuous Glucose Monitorin |
| Generic name | Sensor, glucose, invasive |
| Applicant | Dexcom, Inc. |
| Product code | MDS |
| Received date | Nov 15, 2023 |
| Decision date | Jan 9, 2024 |
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: