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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.
 
DeviceESOPHAGEAL PACING SYSTEM
Generic NameSYSTEM, ESOPHAGEAL PACING
ApplicantCARDIO 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 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR AUTOMATING THE CNC MILLING PROCESS AND THE ADDITION OF A NEW INSPECTION MOLDING MACHINE.
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