FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Analyzer, Data, Obstetric
PMA: P020001
·
Decision Nov 1, 2005
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Analyzer, Data, Obstetric
- Trade Name
- STAN S31 FETAL HEART MONITOR
- PMA Number
- P020001
- Device Class
- FDA Class 3
- Product Code
- HEO
- Generic Name
- Analyzer, data, obstetric
- Regulation Number
- 884.2050
- Medical Specialty
- Obstetrics/Gynecology
- Advisory Committee
- Obstetrics/Gynecology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 1, 2005
- Date Received
- January 2, 2002
- Expedited Review
- N
- Docket Number
- 06M-0009
Advisory Committee Statement
APPROVAL FOR THE STAN S31 FETAL HEART MONITOR. THE DEVICE 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 GESTATION; 3) SINGLETON FETUS; 4) VERTEX PRESENTATION; AND 5) RUPTURED AMNIOTIC MEMBRANES.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HEO | Analyzer, Data, Obstetric | FDA class 3 | Obstetrics/Gynecology |