PMA
P180008: t:slim X2 Insulin Pump with Basal-IQ Technology
FDA PMA · Automated insulin dosing, threshold suspend · Tandem Diabetes Care, Inc.
Key facts
| PMA number | P180008 |
|---|---|
| Trade name | t:slim X2 Insulin Pump with Basal-IQ Technology |
| Generic name | Automated insulin dosing , threshold suspend |
| Applicant | Tandem Diabetes Care, Inc. |
| Owner/operator | Tandem Diabetes Care, Inc. |
| Product code | OZO |
| Approval date | Jun 21, 2018 |
| Docket number | 18M-2462 |
| Notice date | Jul 25, 2018 |
| Establishment registration | 3013756811 |
| FEI number | 3013756811 |
At a glance
- 1–9 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- No Withdrawn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: