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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.
 
DeviceTAPSYSTEM 2A
Classification Namesystem, esophageal pacing
Generic Namesystem, esophageal pacing
Applicant
CARDIOCOMMAND, INC.
4920 west cypress street
suite 110
tampa, FL 33607-3837
PMA NumberP840002
Supplement NumberS007
Date Received10/02/1995
Decision Date10/03/1997
Product Code
LPA[ Registered Establishments with LPA ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site lcoated at Haller Industries, Inc. 4895 West Waters, Suite J, Tampa Florida.
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