PMA
P130007: ANIMAS VIBE SYSTEM
FDA PMA · Pump, infusion, insulin, to be used with invasive glucose sensor · Animas Corp.
Key facts
| PMA number | P130007 |
|---|---|
| Trade name | ANIMAS VIBE SYSTEM |
| Generic name | Pump, infusion, insulin, to be used with invasive glucose sensor |
| Applicant | Animas Corp. |
| Product code | OYC |
| Approval date | Nov 25, 2014 |
| Docket number | 14M-2246 |
| Notice date | Dec 18, 2014 |
| FEI number | 3002920072 |
At a glance
- 10–99 Supplements
- Jul 11, 2018 Latest supplement decision
- Yes Withdrawn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: