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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.
 
DeviceFETAL ACOUSTIC STIMULATOR
Generic NameStimulator, fetal, acoustic
ApplicantGE MEDICAL SYSTEMS, INC.
4502 WOODLAND CORPORATE BLVD
TAMP, FL 33614
PMA NumberP870025
Supplement NumberS008
Date Received08/01/2005
Decision Date03/02/2006
Withdrawal Date 05/30/2014
Product Code 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 ProductNo
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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