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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 TRANSESOPHAGEAL CARDIAC STIMULATOR SYSTEM
Generic NameSYSTEM, ESOPHAGEAL PACING
ApplicantCardio Command
4920 W. Cypress St.
Suite 110
Tampa, FL 33607
PMA NumberP860008
Supplement NumberS022
Date Received06/18/2012
Decision Date07/18/2012
Product Code LPA 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF A NEW PIECE OF EQUIPMENT USED TO CUT AND STRIP PACING WIRES AND SHRINK TUBING.
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