PMA supplement
P120005 S043: DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINIOUS GLUCOSE MONITORING SYSTEM
FDA PMA supplement · 30-Day Notice · Dexcom, Inc.
Key facts
| Original PMA | P120005 |
|---|---|
| Supplement number | S043 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINIOUS GLUCOSE MONITORING SYSTEM |
| Generic name | Sensor, glucose, invasive |
| Applicant | Dexcom, Inc. |
| Product code | MDS |
| Received date | Dec 15, 2015 |
| Decision date | Jan 14, 2016 |
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: