PMA supplement
P140015 S021: t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM
FDA PMA supplement · Normal 180 Day Track No User Fee · Tandem Diabetes Care, Inc.
Key facts
| Original PMA | P140015 |
|---|---|
| Supplement number | S021 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| 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. |
| Product code | OYC |
| Received date | Apr 3, 2017 |
| Decision date | Dec 21, 2017 |
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: