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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.
 
Trade NameNEOVENTA'S STAN S31 FETAL HEART MONITOR
Classification Nameanalyzer, data, obstetric
Generic Nameobstetric data analyzer
Regulation Number884.2050
ApplicantNEOVENTA MEDICAL AB
PMA NumberP020001
Supplement NumberS004
Date Received10/16/2007
Decision Date04/11/2008
Product Code
HEO[ Registered Establishments with HEO ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order 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 gestation; 3) singleton fetus; 4) vertex presentation; and 5) ruptured amniotic membranes.
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