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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameanalyzer, data, obstetric
Generic Nameobstetric data analyzer
Regulation Number884.2050
PMA NumberP020001
Supplement NumberS007
Date Received08/07/2009
Decision Date02/01/2010
Product Code
HEO[ Registered Establishments with HEO ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for various hardware, software, and labeling upgrades including integration of maternal non-invasive blood pressure and oxygen saturation monitoring and alarms. The device, as modified, will be marketed under the trade name stan s31 and is indicated for: monitoring of fetus and mother throughout labor and delivery. The following parameters can 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) 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. St analysis is intended for use in patients with: 1) planned vaginal delivery; 2) >36 weeks gestation; 3) singleton fetus; 4) vertex presentation; and 5) ruptured amniotic membranes.