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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.
 
DeviceEXTERNAL PULSE GENERATOR MODEL 2A, TAPSCOPE 500 SERIES ESOPHAGEAL STETHOSCOPE AND PACING CATHETER, TAPSCOPE 210 ESOPHAGR
Generic NameSYSTEM, ESOPHAGEAL PACING
ApplicantCARDIO COMMAND
4920 WEST CYPRESS ST. STE.110
TAMPA, FL 33607
PMA NumberP860008
Supplement NumberS018
Date Received06/04/2004
Decision Date08/27/2004
Product Code LPA 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE INTERCHANGEABILITY OF EXISTING APPROVED PRODUCTS. THOSE PRODUCTS ARE EXTERNAL PULSE GENERATORS (MODELS 2A, 7A, AND 7B) AND ESOPHAGEAL CATHETER SYSTEMS (MODELS 205, 210, 210S, 1600, 500 SERIES, AND TAPSUL.)
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