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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.
 
DeviceNEOVENTA'S STAN S31 FETAL HEART MONITOR
Generic NameAnalyzer, data, obstetric
Regulation Number884.2050
ApplicantNEOVENTA MEDICAL AB
NORRA AGATAN 32
SE-431 35
MOLNDAL 
PMA NumberP020001
Supplement NumberS006
Date Received09/11/2009
Decision Date11/16/2009
Product Code HEO 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE CLINICAL GUIDELINES. THE DEVICE ASMODIFIED WILL BE MARKETED UNDER THE TRADE NAME STAN S31 FETAL HEART MONITOR AND IS INDICATED FOR USE AS AN ADJUNCT TO FETAL HEART RATE MONITORING TO DETERMINE WHETHER OBSTETRICAL INTERVENTION IS WARRANTED WHEN THERE IS INCREASED RISK OF DEVELOPING METABOLIC ACIDOSIS.THIS DEVICE IS INTENDED FOR USE IN PATIENTS WITH:1) PLANNED VAGINAL DELIVERY;2) >36 COMPLETED WEEKS GESTATION;3) SINGLETON FETUS;4) VERTEX PRESENTATION; AND5) RUPTURED AMNIOTIC MEMBRANES.
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