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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.
 
DeviceTAPCATH AND TAPSCOPE DISPOSABLE TRANSESOPHAGEAL PROBES
Classification Namesystem, esophageal pacing
Generic Namesystem, esophageal pacing
Applicant
CARDIO 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[ Registered Establishments with LPA ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site at cardiocommand, inc. , tampa, florida.
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