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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameanalyzer, data, obstetric
Generic Nameanalyzer, data, obstetric
Regulation Number884.2050
norra agatan 32
se-431 35
PMA NumberP020001
Date Received01/02/2002
Decision Date11/01/2005
Product Code
HEO[ Registered Establishments with HEO ]
Docket Number 06M-0009
Notice Date 01/09/2006
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the stan s31 fetal heart monitor. The device 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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S004 S005 S006 S007 S008 S009