NEOVENTA'S STAN S31 FETAL HEART MONITOR
FDA premarket approval P020001/S006 · decided 2009-11-16
Approval details
- PMA number
- P020001
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- 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
- Date received
- 2009-09-11
- Decision date
- 2009-11-16
- Days to decision
- 66 days
- Decision code
- APPR
- Product code
- HEO
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Molndal
- Statement
- APPROVAL FOR CHANGES TO THE CLINICAL GUIDELINES. THE DEVICE ASMODIFIED WILL BE MARKETED UNDER THE TRADE NAME STAN S31 FETAL HEART MONITOR AND 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.THIS DEVICE IS INTENDED FOR USE IN PATIENTS WITH:1) PLANNED VAGINAL DELIVERY;2) >36 COMPLETED WEEKS GESTATION;3) SINGLETON FETUS;4) VERTEX PRESENTATION; AND5) RUPTURED AMN
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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 |