PMA supplement
P980022 S010: GUARDIAN TELEMETERED GLUCOSE MONITORING SYSTEM (TGMS)
FDA PMA supplement · Panel Track · Medtronic Minimed
Key facts
| Original PMA | P980022 |
|---|---|
| Supplement number | S010 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | GUARDIAN TELEMETERED GLUCOSE MONITORING SYSTEM (TGMS) |
| Generic name | Sensor, glucose, invasive |
| Applicant | Medtronic Minimed |
| Product code | MDS |
| Received date | Nov 29, 2002 |
| Decision date | Jan 7, 2004 |
| Docket number | 12M-0965 |
| Notice date | Sep 12, 2012 |
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: