PMA P020001S007

Device: STAN S31 SYSTEM
Applicant: Neoventa Medical AB
PMA number: P020001
Supplement: S007
Product code: HEO
Decision date: 2010-02-01
Generic name: Analyzer, data, obstetric
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.

Current openFDA PMA Record#

Device: STAN S31 SYSTEM
Applicant: Neoventa Medical AB
PMA number: P020001
Supplement: S007
Product code: HEO
Generic name: Analyzer, data, obstetric
Decision date: 2010-02-01
Decision code: APPR
Date received: 2009-07-23
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.