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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.
 
DeviceSTAT-PACE II ESOPHAGEAL PACING SYSTEM
Generic NameSYSTEM, ESOPHAGEAL PACING
ApplicantCardiocommand, Inc.
4920 W. Cypress St.
Suite 110
Tampa, FL 33607
PMA NumberP840002
Supplement NumberS008
Date Received01/03/1996
Decision Date05/07/1998
Product Code LPA 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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