PMA supplement
P130007 S004: ANIMAS VIBE SYSTEM
FDA PMA supplement · Panel Track · Animas Corp.
Key facts
| Original PMA | P130007 |
|---|---|
| Supplement number | S004 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | ANIMAS VIBE SYSTEM |
| Generic name | Sensor, glucose, invasive |
| Applicant | Animas Corp. |
| Product code | MDS |
| Received date | Apr 30, 2015 |
| Decision date | Dec 24, 2015 |
| Docket number | 16M-0120 |
| Notice date | Feb 12, 2016 |
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: