PMA supplement
P140015 S020: t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM
FDA PMA supplement · Panel Track · Tandem Diabetes Care, Inc.
Key facts
| Original PMA | P140015 |
|---|---|
| Supplement number | S020 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM |
| Generic name | Pump, infusion, insulin, to be used with invasive glucose sensor |
| Applicant | Tandem Diabetes Care, Inc. |
| Product code | OYC |
| Received date | Mar 1, 2017 |
| Decision date | Aug 25, 2017 |
| Docket number | 17M-5262 |
| Notice date | Sep 5, 2017 |
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: