PMA
P990053: OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
FDA PMA · Oximeter, fetal pulse · Covidien, LLC
Key facts
| PMA number | P990053 |
|---|---|
| Trade name | OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM |
| Generic name | Oximeter, fetal pulse |
| Applicant | Covidien, LLC |
| Owner/operator | Covidien llc |
| Product code | MMA |
| Approval date | May 12, 2000 |
| Docket number | 00M-1448 |
| Notice date | Aug 24, 2000 |
| Establishment registration | 1282497 |
| FEI number | 1282497 |
At a glance
- 10–99 Supplements
- Jun 24, 2005 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- Yes Withdrawn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: