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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 NumberS008
Date Received07/08/2011
Decision Date08/04/2011
Product Code
HEO[ Registered Establishments with HEO ]
Advisory Committee Obstetrics/Gynecology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an inspection test for the device.
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