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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSTAN S31 SYSTEM
Generic NameAnalyzer, data, obstetric
Regulation Number884.2050
ApplicantNEOVENTA MEDICAL AB
NORRA AGATAN 32
SE-431 35
MOLNDAL 
PMA NumberP020001
Supplement NumberS007
Date Received07/23/2009
Decision Date02/01/2010
Product Code HEO 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR VARIOUS HARDWARE, SOFTWARE, AND LABELING UPGRADES INCLUDINGINTEGRATION OF MATERNAL NON-INVASIVE BLOOD PRESSURE AND OXYGEN SATURATION MONITORING ANDALARMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STAN S31 AND ISINDICATED FOR:MONITORING OF FETUS AND MOTHER THROUGHOUT LABOR AND DELIVERY. THE FOLLOWING PARAMETERSCAN BE MONITORED WITH STAN S31: 1) FETAL HEART RATE; 2) FETAL ECG WAVEFORM; 3) UTERINE ACTIVITY; 4) MATERNAL NON-INVASIVE BLOOD PRESSURE; 5) MATERNAL SPO2; AND 6) MATERNAL HEART RATE.THE STAN S31 FETAL HEART MONITOR FETAL ECG ANALYSIS FEATURE (ST ANALYSIS) ISINDICATED AS AN ADJUNCT TO FETAL HEART RATE MONITORING TO DETERMINE WHETHER OBSTETRICALINTERVENTION IS WARRANTED WHEN THERE IS INCREASED RISK OF DEVELOPING METABOLIC ACIDOSIS.ST ANALYSIS IS INTENDED FOR USE IN PATIENTS WITH:1) PLANNED VAGINAL DELIVERY;2) >36 WEEKS GESTATION;3) SINGLETON FETUS;4) VERTEX PRESENTATION; AND5) RUPTURED AMNIOTIC MEMBRANES.
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