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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 NameFETAL ACOUSTIC STIMULATOR
Classification Namestimulator, fetal, acoustic
Generic Namefetal acoustic stimulator
ApplicantWIPRO GE HEALTHCARE
PMA NumberP870025
Supplement NumberS010
Date Received09/12/2011
Decision Date10/12/2011
Product Code
MCP[ Registered Establishments with MCP ]
Advisory Committee Obstetrics/Gynecology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to the suppliers for components of the fast device.
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