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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
Molndal SE-431 35
PMA NumberP020001
Supplement NumberS008
Date Received07/07/2011
Decision Date08/04/2011
Product Code HEO 
Advisory Committee Obstetrics/Gynecology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF AN INSPECTION TEST FOR THE DEVICE.
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