PMA supplement
P020001 S004: NEOVENTA'S STAN S31 FETAL HEART MONITOR
FDA PMA supplement · Normal 180 Day Track · Neoventa Medical AB
Key facts
| Original PMA | P020001 |
|---|---|
| Supplement number | S004 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | NEOVENTA'S STAN S31 FETAL HEART MONITOR |
| Generic name | Analyzer, data, obstetric |
| Applicant | Neoventa Medical AB |
| Product code | HEO |
| Received date | Oct 11, 2007 |
| Decision date | Apr 11, 2008 |
At a glance
- No Expedited review granted
- No Approval order on file
- No 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: