NEOVENTA'S STAN S31 FETAL HEART MONITOR
FDA premarket approval P020001/S004 · decided 2008-04-11
Approval details
- PMA number
- P020001
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- 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
- 2007-10-11
- Decision date
- 2008-04-11
- Days to decision
- 183 days
- Decision code
- APPR
- Product code
- HEO
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Molndal
- Statement
- APPROVAL FOR MODIFICATIONS TO THE STAN FETAL HEART RATE CLASSIFICATION AND THE STAN SIMPLIFIED CLINICAL GUIDELINES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STAN S31 FETAL HEART MONITOR AND IS INDICATED 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 GESTATI
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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 |