PMA
P050020: FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITOR
FDA PMA · Sensor, glucose, invasive · Abbott Laboratories
Key facts
| PMA number | P050020 |
|---|---|
| Trade name | FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITOR |
| Generic name | Sensor, glucose, invasive |
| Applicant | Abbott Laboratories |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MDS |
| Approval date | Mar 12, 2008 |
| Docket number | 08M-0207 |
| Notice date | Apr 1, 2008 |
| Establishment registration | 2954323 |
| FEI number | 3002803444 |
At a glance
- 10–99 Supplements
- Jul 6, 2011 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: