STAN S31 FETAL HEART MONITOR
FDA premarket approval P020001/S002 · decided 2007-09-26
Approval details
- PMA number
- P020001
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STAN S31 FETAL HEART MONITOR
- Generic name
- Analyzer, data, obstetric
- Applicant
- Neoventa Medical AB
- Date received
- 2007-08-13
- Decision date
- 2007-09-26
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- HEO
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Molndal
- Statement
- APPROVAL FOR A CHANGE TO THE LCD PANEL MODEL, POWER SUPPLY UNIT, AND ADDITION OF AN INTERNAL FAN. THE DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO FETAL HEART RATE MONITORING TO DETERMINE WHETHER OBSTETRICAL INTERVENTION IS WARRANTED WHEN THERE IS INCREASED RISK OF DEVELOPING METABOLIC ACIDOSIS. THE DEVICE IS INTENDED FOR USE IN PATIENTS WITH: 1) PLANNED VAGINAL DELIVERY; 2) >36 COMPLETED WEEKS GESTATION; 3) SINGLETON FETUS; 4) VERTEX PRESENTATION; AND 5) RUPTURED AMNIOTIC MEMBRANES.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) (K243291) | Neoventa Medical AB | 2025-01-17 |