PMA supplement
P050012 S001: SEVEN PLUS CONTINOUS GLUCOSE MONITORING SYSTEM
FDA PMA supplement · Panel Track · Dexcom, Inc.
Key facts
| Original PMA | P050012 |
|---|---|
| Supplement number | S001 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | SEVEN PLUS CONTINOUS GLUCOSE MONITORING SYSTEM |
| Generic name | Sensor, glucose, invasive |
| Applicant | Dexcom, Inc. |
| Product code | MDS |
| Received date | Jun 19, 2006 |
| Decision date | May 31, 2007 |
| Docket number | 07M-0255 |
| Notice date | Jun 28, 2007 |
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: