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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.
 
DeviceSTAN S31 FETAL HEART MONITOR
Generic NameAnalyzer, data, obstetric
Regulation Number884.2050
ApplicantNeoventa Medical AB
Norra Agatan 32
Molndal SE-431 35
PMA NumberP020001
Supplement NumberS009
Date Received09/21/2011
Decision Date11/18/2011
Product Code HEO 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF AN ACCESSORY, THE STAN VIEWER LIVE, WHICH ALLOWS REMOTE VIEWING OF AN ONGOING STAN S31 RECORDING.
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