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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.
 
DeviceFETAL ACOUSTIC STIMULATOR (FAST)
Classification Namestimulator, fetal, acoustic
Generic Namestimulator, fetal, acoustic
Applicant
GE MEDICAL SYSTEMS, INC.
4502 woodland corporate blvd
tamp, FL 33614
PMA NumberP870025
Supplement NumberS009
Date Received08/05/2009
Decision Date04/23/2010
Product Code
MCP[ Registered Establishments with MCP ]
Advisory Committee Obstetrics/Gynecology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a change in supplier of a coil assembly.
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