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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.
 
DeviceARZCO OCTAPOLAR ESOPHAGEAL CARDIAC STIMULATORS
Generic NameSYSTEM, ESOPHAGEAL PACING
ApplicantCardio Command
4920 W. Cypress St.
Suite 110
Tampa, FL 33607
PMA NumberP860008
Supplement NumberS011
Date Received06/20/1991
Decision Date08/06/1992
Product Code LPA 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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