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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.
 
DeviceESOPHAGEAL PACING SYSTEM
Classification Namesystem, esophageal pacing
Generic Namesystem, esophageal pacing
Applicant
CARDIO COMMAND
4920 west cypress st. ste.110
tampa, FL 33607
PMA NumberP860008
Supplement NumberS020
Date Received10/24/2011
Decision Date03/06/2012
Product Code
LPA[ Registered Establishments with LPA ]
Advisory Committee Cardiovascular
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 automating the cnc milling process and the addition of a new inspection molding machine.
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