PMA
P150029: IPRO2 CGM SYSTEM WITH ENLITE SENSOR
FDA PMA · Sensor, glucose, invasive · Medtronic Minimed
Key facts
| PMA number | P150029 |
|---|---|
| Trade name | IPRO2 CGM SYSTEM WITH ENLITE SENSOR |
| Generic name | Sensor, glucose, invasive |
| Applicant | Medtronic Minimed |
| Owner/operator | Medtronic |
| Product code | MDS |
| Approval date | Jun 17, 2016 |
| Docket number | 16m-1755 |
| Notice date | Jun 24, 2016 |
| Establishment registration | 2032227 |
| FEI number | 3003166194 |
At a glance
- 10–99 Supplements
- Apr 29, 2022 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: