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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.
 
DeviceESOPHAGEAL CARDIAC RECORDING & PACING CATHETER
Generic NameSYSTEM, ESOPHAGEAL PACING
ApplicantCardio Command
4920 W. Cypress St.
Suite 110
Tampa, FL 33607
PMA NumberP860008
Supplement NumberS009
Date Received04/12/1990
Decision Date03/25/1991
Product Code LPA 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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