PMA
P120005: DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
FDA PMA · Sensor, glucose, invasive · Dexcom, Inc.
Key facts
| PMA number | P120005 |
|---|---|
| Trade name | DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM |
| Generic name | Sensor, glucose, invasive |
| Applicant | Dexcom, Inc. |
| Owner/operator | DEXCOM, INC. |
| Product code | MDS |
| Approval date | Oct 5, 2012 |
| Docket number | 12M-1049 |
| Notice date | Oct 12, 2012 |
| Establishment registration | 3004753838 |
| FEI number | 3004753838 |
At a glance
- 10–99 Supplements
- Jan 9, 2024 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: