PMA supplement
P120005 S031: DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA PMA supplement · Panel Track · Dexcom, Inc.
Key facts
| Original PMA | P120005 |
|---|---|
| Supplement number | S031 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Generic name | Sensor, glucose, invasive |
| Applicant | Dexcom, Inc. |
| Product code | MDS |
| Received date | Nov 26, 2014 |
| Decision date | May 22, 2015 |
| Docket number | 15M-1959 |
| Notice date | Jun 11, 2015 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: