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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
Classification Namestimulator, fetal, acoustic
Generic Namestimulator, fetal, acoustic
Applicant
GE MEDICAL SYSTEMS, INC.
4502 woodland corporate blvd
tamp, FL 33614
PMA NumberP870025
Supplement NumberS008
Date Received08/01/2005
Decision Date03/02/2006
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 No
Approval Order Statement 
Approval for vendor changes for the following components: die cast frame and printed circuit board (pcb) and a change in adhesive material.
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