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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.
 
Trade NameEXTERNAL PULSE GENERATOR MODEL 2A, TAPSCOPE 500 SERIES ESOPHAGEAL STETHOSCOPE AND PACING CATHETER, TAPSCOPE 210 ESOPHAGR
Classification Namesystem, esophageal pacing
Generic Nameexternal pulse generator
ApplicantCARDIO COMMAND
PMA NumberP840002
Supplement NumberS012
Date Received06/04/2004
Decision Date08/27/2004
Product Code
LPA[ Registered Establishments with LPA ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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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