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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.
 
DeviceTAPCATH AND TAPSCOPE DISPOSABLE TRANSESOPHAGEAL PROBES
Generic NameSYSTEM, ESOPHAGEAL PACING
ApplicantCARDIO COMMAND
4920 WEST CYPRESS ST. STE.110
TAMPA, FL 33607
PMA NumberP860008
Supplement NumberS017
Date Received01/16/2004
Decision Date02/03/2005
Product Code LPA 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE AT CARDIOCOMMAND, INC., TAMPA, FLORIDA.
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