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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.
 
DeviceTAP SYSTEM 2A
Generic NameSYSTEM, ESOPHAGEAL PACING
ApplicantCardiocommand, Inc.
4920 W. Cypress St.
Suite 110
Tampa, FL 33607
PMA NumberP840002
Supplement NumberS013
Date Received05/28/2015
Decision Date03/24/2016
Product Code LPA 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Cardiocommand, Inc., in Tampa, Florida, for the manufacture of the Tapsystem Model 2A device.
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