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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.
 
DeviceCOROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR, 0146
Classification Namestimulator, fetal, acoustic
Generic Namestimulator, fetal, acoustic
Applicant
GE MEDICAL SYSTEMS, INC.
4502 woodland corporate blvd
tamp, FL 33614
PMA NumberP870025
Supplement NumberS011
Date Received09/10/2012
Decision Date10/10/2012
Product Code
MCP[ Registered Establishments with MCP ]
Advisory Committee Obstetrics/Gynecology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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