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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
Generic NameStimulator, fetal, acoustic
ApplicantGe Medical Systems, Inc.
4502 Woodland Corporate Blvd.
Tampa, FL 33614
PMA NumberP870025
Supplement NumberS004
Date Received11/09/1995
Decision Date02/01/1996
Withdrawal Date05/30/2014
Product Code MCP 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES IN THE QUALITY CONTROL AND MANUFACUTRING PRACTICES FOR THE TRANSDUCER IN COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR
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