PMA
P020001: STAN S31 FETAL HEART MONITOR
FDA PMA · Analyzer, data, obstetric · Neoventa Medical AB
Key facts
| PMA number | P020001 |
|---|---|
| Trade name | STAN S31 FETAL HEART MONITOR |
| Generic name | Analyzer, data, obstetric |
| Applicant | Neoventa Medical AB |
| Owner/operator | Neoventa Medical AB |
| Product code | HEO |
| Approval date | Nov 1, 2005 |
| Docket number | 06M-0009 |
| Notice date | Jan 9, 2006 |
| Establishment registration | 3004729605 |
| FEI number | 3005011303 |
At a glance
- 1–9 Supplements
- Nov 18, 2011 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: