PMA
P140015: T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
FDA PMA · Pump, infusion, insulin, to be used with invasive glucose sensor · Tandem Diabetes Care, Inc.
Key facts
| PMA number | P140015 |
|---|---|
| Trade name | T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM |
| Generic name | Pump, infusion, insulin, to be used with invasive glucose sensor |
| Applicant | Tandem Diabetes Care, Inc. |
| Owner/operator | Tandem Diabetes Care, Inc. |
| Product code | OYC |
| Approval date | Sep 8, 2015 |
| Docket number | 15M-3376 |
| Notice date | Oct 15, 2015 |
| Establishment registration | 3007981285 |
| FEI number | 3007981285 |
At a glance
- 10–99 Supplements
- Dec 19, 2019 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- No Withdrawn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: