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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.
 
DeviceCOROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR, 0146
Generic NameStimulator, fetal, acoustic
ApplicantGE MEDICAL SYSTEMS, INC.
4502 WOODLAND CORPORATE BLVD
TAMP, FL 33614
PMA NumberP870025
Supplement NumberS011
Date Received09/10/2012
Decision Date10/10/2012
Withdrawal Date 05/30/2014
Product Code MCP 
Advisory Committee Obstetrics/Gynecology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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