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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.
Classification Namestimulator, fetal, acoustic
Generic Namestimulator, fetal, acoustic
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.